SWAB ALCOHOL 100 BX 1200 BRAZIL

Additional Manufacturer Narrative

(B)(4). INVESTIGATION SUMMARY: LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT FOR SWABS DRY AND THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER ON PACKAGING ON LOT # 8277955. A REVIEW OF RISK MANAGEMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SWABS, DRY AND FOREIGN MATTER ON PACKAGING) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF BD ALCOHOL SWABS FROM LOT # 8277955. CUSTOMER STATES THAT WHEN OPENING THE ALCOHOL SWAB PACKAGING IT WAS VERIFIED THAT IT WAS DRY, IN ADDITION, IT VERIFIED THAT THE PACKAGING HAD A YELLOWISH STAIN. THE PHOTOS WERE EXAMINED AND EXHIBITED SWAB PACKETS WITH A YELLOWISH STAIN ON THE EDGE OF THE SWAB PACKET. HOWEVER, IT IS DIFFICULT TO DETERMINE IF THE SWAB PAD IS DRY SOLELY FROM THE PHOTO. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8277955. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (STAINING). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DRY SWAB). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD (B)(4). ON 25TH SEP 2020, (B)(4) RECEIVED A PHOTO OF FM ON A BD ALCOHOL SWAB PACKAGING FROM BATCH 8277955 MATERIAL 326915. A VISUAL EVALUATION OF THE SWAB FOUND YELLOW STAIN AT BOTTOM OF THE PACKAGING. THE SWABS WERE PRODUCED ON 15OCT2018 ¿ 16OCT2018 ON THE CIRCLES OPERATION. PROCESS: PROCESS SUMMARY: THIS MACHINE IS DESIGNED TO CONVERT RAW MATERIALS INTO PACKAGED ALCOHOL SWABS. PAD ARE CUT, SATURATED WITH ALCOHOL, AND SEALED INTO POUCHES. THE POUCHES ARE CUT AND PERFORATED INTO TANDEM PACKS. 50 TANDEM PACKAGES (EQUAL TO 100 SWAB POUCHES) ARE PLACED INTO A CARTON FOR CUSTOMER USE. 12 CARTONS ARE PLACED INTO A CASE TO BE SENT TO DISTRIBUTION CENTERS. ALCOHOL SWABS ARE MANUFACTURED ON LINES DEDICATED TO THIS PROCESS ONLY. INVESTIGATION: THE DHR, L2L DISPATCHES, LOGBOOKS AND QUALITY NOTIFICATIONS WERE ALL REVIEWED. NOTHING WAS FOUND PERTAINING TO THIS TYPE OF COMPLAINT. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED. ROOT CAUSE: ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 BRAZIL HAD FOREIGN MATTER ON IT. THIS OCCURRED ON 4 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN OPENING THE ALCOHOL SWAB PACKAGING IT WAS VERIFIED THAT IT WAS DRY, IN ADDITION, IT VERIFIED THAT THE PACKAGING HAD A YELLOWISH STAIN. FOUR UNITS WERE OBSERVED WITH THE SAME DEFECTS.