SWAB ALCOHOL 100 BX 1200

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

Description of Event or Problem

CONSUMER REPORTED FINDING THE WRONG PRODUCT IN HIS NEW BOX ALCOHOL SWABS. STATED, HALF THE BOX CONTAINED BD ALCOHOL SWABS AND THE OTHER HALF CONTAINED, COVIDIEN WEBCOL ALCOHOL SWABS. STATED, HE PURCHASED THE BOX A MONTH AGO BUT STARTED USING THEM TODAY. LOT: 4127007. CATALOG: 326895. DATE OF EVENT: 2024-30-12. SAMPLES: YES (B)(4).