FILTER RETENTION PLATE

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT JK100 - FILTER RETENTION PLATE VIA INFORMATION RECEIVED FROM MW5147663. ACCORDING TO THE COMPLAINT DESCRIPTION, THE RETENTION PLATES ARE LEAVING BLACK PARTICLES INSIDE OF STERILE SURGICAL TRAY. THERE WAS NO PATIENT HARM. THIS MEDWATCH IS BEING SENT AS A FEEDBACK TO THE FDA IN REFERENCE TO THE MEDWATCH: 5147663 ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3 AND 803.50, THIS EVENT IS NOT CONSIDERED / DEEMED AS A REPORTABLE EVENT FOR THE FOLLOWING REASON: - NO DEATH OR SERIOUS INJURY - NO MALFUNCTION THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR THE REPORTING DECISION IS BASED UPON THE REVIEW OF THE APPLICABLE RISK ANALYSIS. THE REVIEW OF THE RISK ANALYSIS REVEALED THAT THE APPLICABLE FAILURE MODE IS RATED WITH A SEVERITY OF 1(5). BASED UPON RISK MANAGEMENT REVIEW, WE CURRENTLY CONCLUDE THAT EVEN IF THE REPORTED FAILURE IS TO REOCCUR, NO SERIOUS INJURY FOR PATIENT, USER OR THIRD PARTY IS TO BE EXPECTED. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 - CODES UPDATED. H10 - RELATED REPORT ADDED. INVESTIGATION RESULTS: THE COMPLAINED PRODUCT WAS NOT RECEIVED. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. FURTHERMORE, THE AFFECTED BATCH COULD NOT BE IDENTIFIED. IN 2021, 4 DELIVERIES WERE SENT TO THE CUSTOMER. FROM 01/01/2023 TO 09/01/2024, 45 BATCHES WERE PRODUCED WITH A PURCHASE QUANTITY OF (B)(4) PER BATCH. IN THE LAST FIVE YEARS, THERE WERE NO IDENTIFIED SIMILAR COMPLAINTS. THIS MEDWATCH IS BEING SENT AS A FEEDBACK TO THE FDA IN REFERENCE TO THE MEDWATCH: 5147663 ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3 AND 803.50, THIS EVENT IS NOT CONSIDERED / DEEMED AS A REPORTABLE EVENT FOR THE FOLLOWING REASON: NO DEATH OR SERIOUS INJURY. NO MALFUNCTION THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. THE REPORTING DECISION IS BASED UPON THE REVIEW OF THE APPLICABLE RISK ANALYSIS. THE REVIEW OF THE RISK ANALYSIS REVEALED THAT THE APPLICABLE FAILURE MODE IS RATED WITH A SEVERITY OF 1(5). BASED UPON RISK MANAGEMENT REVIEW, WE CURRENTLY CONCLUDE THAT EVEN IF THE REPORTED FAILURE IS TO REOCCUR, NO SERIOUS INJURY FOR PATIENT, USER OR THIRD PARTY IS TO BE EXPECTED. CONCLUSION/PREVENTIVE MEASURES: ON THE BASIS OF THE CURRENT INFORMATION AND WITHOUT A PRODUCT FOR INVESTIGATION, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.