SWAB ALCOHOL 100 BX 1200 ASIA PACIFIC

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: LEVEL A 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 1ST RELATED COMPLAINT FOR FOREIGN MATTER (BROWN TAPE) ON LOT # 9261602. INVESTIGATION SUMMARY: CUSTOMER RETURNED THREE (3) USED BD ALCOHOL SWABS FROM LOT 9261602 (TWO FROM LINE 6 AND ONE FROM LINE 5). CONSUMER REPORTED THE BROWN TAPE WAS FOUND. ALL THREE RETURNED SWABS WERE EXAMINED, AND IT WAS OBSERVED THAT SPLICING TAPE WAS ATTACHED ALL THREE OF THE SWABS. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THE OBSERVED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9261602. 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 (SPLICING TAPE ON SWABS). 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 23JAN2020, HOLDREGE RECEIVED A PHOTO OF FM ON THE PAD FROM A BD ALCOHOL SWAB FROM BATCH 9261602 MATERIAL 326894 A VISUAL EVALUATION OF THE SWABS FOUND SPLICING TAPE ACROSS ONE END OF THE PAD. THE SWABS WERE PRODUCED ON 29SEP2019 ¿ 03OCT2019 ON THE CIRCLES OPERATION. PROCESS: AT THE SWAB MACHINES, EVERY PAD ROLL IS SPLICED TOGETHER WITH ¿BROWN¿ TAPE LIKE WHAT IS SEEN IN THE COMPLAINT. THE TAPE IS MANUALLY APPLIED, BY THE SWAB ASSOCIATE, ONTO THE END OF THE PAD ROLL THAT IS ON THE MACHINE ONTO THE NEW PAD ROLL THAT IS BEING INTRODUCED. AN EYE (SICK EYE) ON EACH SIDE OF THE PAD ROLL (LANE 1 & LANE 10) IS USED TO DETECT THE TAPED SPLICE. WHEN THE EYE DETECTS THE SLICE, IT COUNTS (SO MANY CYCLES) AND AUTOMATICALLY REJECTS THE SWABS, PRIOR TO THE CARTON AN ACCUMULATOR INTO A WASTE BIN. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS." 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 ASIA PACIFIC HAD FOREIGN MATERIAL ON IT. THIS OCCURRED ON 5 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BROWN TAPE WAS FOUND.