ALCOHOL SWAB PREMIUM 3000 UNITS BLK

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR PACKETS DAMAGED/HOLE, DAMAGED/LEAKAGE AND INCORRECT MISSING LABEL CONTENT ON LOT # 9343289. CUSTOMER RETURNED PHOTOS OF BD ALCOHOL SWABS FROM LOT # 9343289. CUSTOMER STATES THAT THERE ARE WIPES WITH LEAKAGE AND WIPES WITH ILLEGIBLE LEGENDS WERE FOUND. THE PHOTOS WERE EXAMINED AND EXHIBITED A HOLE IN THE SWAB PACKET WHICH COULD LEAD TO LEAKAGE AND SMEARING OF THE INK ON THE BACK OF THE SWAB PAD. SWABS ALSO EXHIBITED MISPRINTED LOT NUMBER AND EXPIRATION DATE INFORMATION PRINTED ON THE BACK OF THE SWAB PADS. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9343289. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200856998] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: "ON 05MAY2020, (B)(4) RECEIVED A PHOTO COMPLAINT FOR PACKETS DAMAGED/HOLE, DAMAGED/LEAKAGE, INCORRECT/MISSING LABEL CONTENT FOR MATERIAL 326903 BATCH# 9343289. PROCESS: THE ALCOHOL SWAB IS PRODUCED BY SLITTING A ROLL OF THE PAD MATERIAL INTO 10 STRIPS TO THE PROPER WIDTHS FOR PACKAGING. A ROLL OF FOIL/PAPER WEB IS SPLIT ON CENTER AND ROUTED SEPARATELY SO THAT THE FOIL SIDES FACE EACH OTHER. THE BOTTOM WEB OF THE SWABS IS PRINTED WITH THE LOT NUMBER. PRIOR TO FINAL SEALING INTO THE POUCH, THE PAD STRIPS ARE CUT TO LENGTH, PLACED ON THE FOIL/PAPER WEB, AND DOSED WITH ALCOHOL. ONCE CUT AND DOSED, THE SWABS ARE PROMPTLY SEALED INTO THE POUCH. THE POUCH MATERIAL IS CUT AND PERFORATED SO AS TO DELIVER 5 TANDEM PACKS PER CYCLE. THE TANDEM PACKS EXIT THE SWAB MACHINE AND ENTER THE ACCUMULATOR WHERE SWABS FROM THE SAME WEB ROWS ARE ACCUMULATED INTO GROUPS OF 50 TANDEM PACKS. THESE GROUPS ARE TRANSFERRED TO THE CARTONER STAGING BUCKETS WHERE AN EMPTY CARTON IS ERECTED AND LOADED WITH THE SWABS. THE BOTTOM FLAP OF THE CARTON IS GLUED WHILE THE TOP FLAP IS TUCKED INTO THE DUST FLAPS. A LOT CODE WILL BE APPLIED TO THE CARTON. THE CARTONS WILL EXIT AND CROSS A CHECKWEIGHER ENROUTE TO THE CASE PACKER WHERE 12 CARTONS WILL BE STACKED, ARRANGED AND LOADED INTO A CASE. AFTER LOADING, THE FLAPS WILL BE CLOSED AND TAPED SHUT, FOLLOWED BY A WRAP-AROUND LABEL APPLIED TO THE CASE. INVESTIGATION: THE PHOTO OF THE COMPLAINT APPEARS TO HAVE A HOLE PUNCTURED ON ONE SIDE OF THE POUCH. ON ONE SIDE OF THE POUCH, THERE APPEARS TO BE A HOLE IN THE MIDDLE OF THE POUCH. A HOLE WOULD ALLOW ALCOHOL TO LEAK OUT, BLEEDING ONTO THE CODING ON THE OUTSIDE OF THE POUCH. THIS WOULD CAUSE THE CODING TO BECOME ILLEGIBLE. EVALUATION: DHR AND L2L ENTRIES WERE LOOKED AT, AND ON (B)(6) 2020 THERE WERE CARTON JAMS PRIOR TO THE CARTONER STOPPED CYCLING. THE CARTON LOAD PUSHER BELT WAS REPLACED. 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 352 ALCOHOL SWABS PREMIUM 3000 UNITS BLK LEGENDS' PRINT WERE ILLEGIBLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING THE SAMPLING, WIPES WITH LEAKAGE AND WIPES WITH ILLEGIBLE LEGENDS WERE FOUND."