J-VAC RESERVOIR UNKNOWN PRODUCT

Additional Manufacturer Narrative

PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: SURG INFECT (LARCHMT). 2025 JUN;26(5):309-318. HTTPS://DOI.ORG/10.1089/SUR.2024.214 EPUB 2025 FEB 24. PMID: 39989099.

Description of Event or Problem

TITLE: IMPACT OF DRAIN REMOVAL TIMING AND PROPHYLACTIC ANTIBIOTIC AGENTS ON SURGICAL SITE INFECTIONS IN HEAD AND NECK RECONSTRUCTION. THE AIM OF THIS STUDY IS TO IDENTIFY RISK FACTORS FOR SURGICAL SITE INFECTION (SSI) AFTER RECONSTRUCTIVE SURGICAL PROCEDURE FOR HEAD AND NECK CANCER, SPECIFICALLY EXAMINING THE INFLUENCE OF DRAIN REMOVAL TIMING. BETWEEN JULY 2017 TO NOVEMBER 2021, THIS PRE-POST STUDY WAS CONDUCTED IN A GROUP OF PATIENTS WITH CLOSED SUCTION DRAINS FOLLOWING RECONSTRUCTIVE SURGICAL PROCEDURE FOR HEAD AND NECK CANCER AT OUR HOSPITAL. THE STUDY WAS EXPLAINED TO EACH PATIENT, AND WRITTEN CONSENT WAS OBTAINED. FROM JULY 2017 TO AUGUST 2019, DRAINS WERE REMOVED AT POD3 AS BEFORE AND STUDIED RETROSPECTIVELY; FROM SEPTEMBER 2019 TO NOVEMBER 2021, AN INTERVENTION STUDY WAS CONDUCTED TO REMOVE DRAINS WITH POD2 REGARDLESS OF THE AMOUNT OF DRAINAGE. THE FINAL SAMPLE ANALYZED WAS 220 CASES (89 IN THE POD2 GROUP AND 131 IN THE POD3 GROUP). THE CLOSED SUCTION DRAIN AND BAG WERE BLAKE DRAINS AND JVAC RESERVOIRS. REPORTED COMPLICATIONS ARE THE FOLLOWING: BLAKE DRAINS (ETHICON). SURGICAL SITE INFECTION (N=32) ON DRAIN REMOVAL POD2 (N=13) AND POD3 (N=19). TREATMENT: NOT REPORTED. HEMATOMA AND LYMPHORRHEA OF HEAD AND NECK AREA (N=14) ON DRAIN REMOVAL POD2 (N=7) AND POD3 (N=7). TREATMENT: NOT REPORTED. POSITIVE DRAIN TIPS CULTURE (N=66) ON DRAIN REMOVAL POD2 (N=16) AND POD3 (N=50) TREATMENT: NOT REPORTED. SHOWED POSITIVE DRAIN TIP CULTURES WHO RECEIVED AMPICILLIN/SULBACTAM (N=29) IN THE POD2 GROUP (N=8), AND IN THE POD3 GROUP (N=21). TREATMENT: NOT REPORTED. SSI (SURGICAL SITE INFECTION) (N=3) OF WHICH THE FIRST PATIENT HAD KLEBSIELLA PNEUMONIAE, THE SECOND PATIENT HAD CORYNEBACTERIUM, AND THE THIRD PATIENT HAD CANDIDA AND ALL HAD POSITIVE CULTURES FROM THE EXUDATE OR WOUND, WHICH WERE MATCHED TO THE DRAIN TIP CULTURES TREATMENT: NONE OF THEM WERE SENSITIVE/SUSCEPTIBLE TO AMPICILLIN/SULBACTAM. DRAIN CULTURE-POSITIVE CASES IN WHICH SSI DID NOT OCCUR (N=26), THE FOLLOWING MICROBES WERE CULTURED: CORYNEBACTERIUM (N = 6), CANDIDA (N = 6), PSEUDOMONAS AERUGINOSA (N = 5), STAPHYLOCOCCUS CAPITIS (N = 3), INCLUDING 2 METHICILLIN-RESISTANT, STAPHYLOCOCCUS EPIDERMIDIS (N = 3, INCLUDING 3 METHICILLIN-RESISTANT), PROPIONIBACTERIUM ACNES (N = 2), COAGULASE-NEGATIVE STAPHYLOCOCCI (N = 1), ESCHERICHIA COLI (N = 1), STAPHYLOCOCCUS CAPRAE (N = 1, METHICILLIN-RESISTANT), STAPHYLOCOCCUS HOMINIS (N = 1, METHICILLIN-RESISTANT), AND ASPERGILLUS (N = 1). TREATMENT: ONLY ONE CASE WAS SUSCEPTIBLE TO AMPICILLIN/SULBACTAM. TESTED POSITIVE DRAIN TIP CULTURES IN THE AMPICILLIN GROUP (N=27) IN THE POD2 GROUP (N=5) AND IN THE POD3 GROUP (N=22). TREATMENT: NOT REPORTED SSI (N=7) OF WHICH THERE WERE STAPHYLOCOCCUS EPIDERMIDIS (THREE METHICILLIN-RESISTANT) (N=3), KLEBSIELLA OXYTOCA (N=2), PSEUDOMONAS AERUGINOSA (N=1), STAPHYLOCOCCUS AUREUS (N=1), AND WAS CITROBACTER KOSERI (N=1) IN THE AMPICILLIN GROUP TREATMENT: NONE WERE SUSCEPTIBLE TO PERI-OPERATIVE PROPHYLAXIS. SSI CASES HAD POSITIVE CULTURES FROM THE EXUDATE OR WOUND (N=4); OF THESE, FOUR (TWO METHICILLIN-RESISTANT STAPHYLOCOCCUS EPIDERMIDIS, ONE STAPHYLOCOCCUS AUREUS, ONE PSEUDOMONAS AERUGINOSA, AND ONE KLEBSIELLA OXYTOCA) MATCHED THE DRAIN TIP CULTURE TREATMENT: NONE SHOWED SENSITIVITY TO AMPICILLIN. POSITIVE DRAIN TIP CULTURES WITHOUT SSI IN THE AMPICILLIN GROUP (N=20), HAD STAPHYLOCOCCUS EPIDERMIDIS (INCLUDING 5 METHICILLIN-RESISTANT) (N=12), AND HAD STAPHYLOCOCCUS AUREUS (INCLUDING 2 METHICILLIN-RESISTANT) (N=6), AND THERE WERE ALSO CORYNEBACTERIUM (N = 5), STAPHYLOCOCCUS SACCHAROLYTICUS (N = 1), KLEBSIELLA OXYTOCA (N = 1), PREVOTELLA (N = 1), FUSOBACTERIUM (N = 1), MORAXELLA (N = 1), STREPTOCOCCUS CONSTELLATUS (N = 1), NEISSERIA (N = 1), BACILLUS (N = 1), SERRATIA MARCESCENS (N = 1), AND CANDIDA (N = 1). TREATMENT: ONLY ONE CASE WAS SUSCEPTIBLE TO AMPICILLIN. JVAC RESERVOIRS (ETHICON). SURGICAL SITE INFECTION (N=32) ON DRAIN REMOVAL POD2 (N=13) AND POD3 (N=19). TREATMENT: NOT REPORTED. HEMATOMA AND LYMPHORRHEA OF HEAD AND NECK AREA (N=14) ON DRAIN REMOVAL POD2 (N=7) AND POD3 (N=7). TREATMENT: NOT REPORTED. POSITIVE DRAIN TIPS CULTURE (N=66) ON DRAIN REMOVAL POD2 (N=16) AND POD3 (N=50) TREATMENT: NOT REPORTED. SHOWED POSITIVE DRAIN TIP CULTURES WHO RECEIVED AMPICILLIN/SULBACTAM (N=29) IN THE POD2 GROUP (N=8), AND IN THE POD3 GROUP (N=21). TREATMENT: NOT REPORTED. SSI (SURGICAL SITE INFECTION) (N=3) OF WHICH THE FIRST PATIENT HAD KLEBSIELLA PNEUMONIAE, THE SECOND PATIENT HAD CORYNEBACTERIUM, AND THE THIRD PATIENT HAD CANDIDA AND ALL HAD POSITIVE CULTURES FROM THE EXUDATE OR WOUND, WHICH WERE MATCHED TO THE DRAIN TIP CULTURES TREATMENT: NONE OF THEM WERE SENSITIVE/SUSCEPTIBLE TO AMPICILLIN/SULBACTAM. DRAIN CULTURE-POSITIVE CASES IN WHICH SSI DID NOT OCCUR (N=26), THE FOLLOWING MICROBES WERE CULTURED: CORYNEBACTERIUM (N = 6), CANDIDA (N = 6), PSEUDOMONAS AERUGINOSA (N = 5), STAPHYLOCOCCUS CAPITIS (N = 3), INCLUDING 2 METHICILLIN-RESISTANT, STAPHYLOCOCCUS EPIDERMIDIS (N = 3, INCLUDING 3 METHICILLIN-RESISTANT), PROPIONIBACTERIUM ACNES (N = 2), COAGULASE-NEGATIVE STAPHYLOCOCCI (N = 1), ESCHERICHIA COLI (N = 1), STAPHYLOCOCCUS CAPRAE (N = 1, METHICILLIN-RESISTANT), STAPHYLOCOCCUS HOMINIS (N = 1, METHICILLIN-RESISTANT), AND ASPERGILLUS (N = 1). TREATMENT: ONLY ONE CASE WAS SUSCEPTIBLE TO AMPICILLIN/SULBACTAM. TESTED POSITIVE DRAIN TIP CULTURES IN THE AMPICILLIN GROUP (N=27) IN THE POD2 GROUP (N=5) AND IN THE POD3 GROUP (N=22). TREATMENT: NOT REPORTED. SSI (N=7) OF WHICH THERE WERE STAPHYLOCOCCUS EPIDERMIDIS (THREE METHICILLIN-RESISTANT) (N=3), KLEBSIELLA OXYTOCA (N=2), PSEUDOMONAS AERUGINOSA (N=1), STAPHYLOCOCCUS AUREUS (N=1), AND WAS CITROBACTER KOSERI (N=1) IN THE AMPICILLIN GROUP. TREATMENT: NONE WERE SUSCEPTIBLE TO PERI-OPERATIVE PROPHYLAXIS. SSI CASES HAD POSITIVE CULTURES FROM THE EXUDATE OR WOUND (N=4); OF THESE, FOUR (TWO METHICILLIN-RESISTANT STAPHYLOCOCCUS EPIDERMIDIS, ONE STAPHYLOCOCCUS AUREUS, ONE PSEUDOMONAS AERUGINOSA, AND ONE KLEBSIELLA OXYTOCA) MATCHED THE DRAIN TIP CULTURE TREATMENT: NONE SHOWED SENSITIVITY TO AMPICILLIN. POSITIVE DRAIN TIP CULTURES WITHOUT SSI IN THE AMPICILLIN GROUP (N=20), HAD STAPHYLOCOCCUS EPIDERMIDIS (INCLUDING 5 METHICILLIN-RESISTANT) (N=12), AND HAD STAPHYLOCOCCUS AUREUS (INCLUDING 2 METHICILLIN-RESISTANT) (N=6), AND THERE WERE ALSO CORYNEBACTERIUM (N = 5), STAPHYLOCOCCUS SACCHAROLYTICUS (N = 1), KLEBSIELLA OXYTOCA (N = 1), PREVOTELLA (N = 1), FUSOBACTERIUM (N = 1), MORAXELLA (N = 1), STREPTOCOCCUS CONSTELLATUS (N = 1), NEISSERIA (N = 1), BACILLUS (N = 1), SERRATIA MARCESCENS (N = 1), AND CANDIDA (N = 1). TREATMENT: ONLY ONE CASE WAS SUSCEPTIBLE TO AMPICILLIN. IN CONCLUSION, IN THIS STUDY OF PATIENTS UNDERGOING RECONSTRUCTIVE SURGICAL PROCEDURE FOR HEAD AND NECK CANCER, THE LESION SITE BEING THE ORAL CAVITY AND THE PROPHYLACTIC ANTIBIOTIC AGENTS BEING AMPICILLIN WERE SUBSTANTIAL RISK FACTORS FOR SSI. IN CONTRAST, DRAIN REMOVAL ON POD3 WAS NOT A SUBSTANTIAL RISK FACTOR FOR SSI. REMOVING DRAINS ON POD2 IS PREFERABLE COMPARED WITH REMOVAL ON POD3 BECAUSE THERE WAS NO SUBSTANTIAL DIFFERENCE IN OTHER COMPLICATIONS SUCH AS HEMATOMA AND LYMPHORRHEA IN THE HEAD AND NECK BETWEEN REMOVING DRAINS ON POD2 AND REMOVING THEM ON POD3.