SWAB ALCOHOL 100 BX 1200

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS) INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO DEFINITIVE ROOT CAUSE DETERMINED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

Description of Event or Problem

ON 1/30/2025, PRODUCTION PERSONNEL NOTICED SOME ALCOHOL SWAB PACKAGING (CIA60004) FROM EMBECTA LOT: 4197035 THAT CONTAINED MISALIGNED/MISSING PRINTED INFORMATION (LOT NUMBER, EXPIRATION, AND DATE OF MANUFACTURE). SO FAR, WE HAVE FOUND 3 PACKS WITH DUPLICATE INFORMATION AND 2 PACKS WITH NO INFORMATION (BLANK). WE ARE CURRENTLY PERFORMING 100% INSPECTION WHICH SLOWS OUR PRODUCT OUTPUT RATE. IF YOU NEED THESE DEFECTIVE SWABS RETURNED, PLEASE GIVE ME CONTACT AND ADDRESS INFORMATION, INCLUDING COURIER ACCOUNT NUMBER. PLEASE OPEN AN INVESTIGATION INTO THE POTENTIAL ROOT CAUSE AND ISSUE SCOPE AND RETURN THE COMPLETED REPORT WITHIN 21 DAYS, UNLESS YOUR PROCEDURE ALLOWS FOR A LONGER INVESTIGATION TIME FRAME. SINCERELY.