SWAB ALCOHOL 100 BX 1200

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. 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 SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

Description of Event or Problem

THE CONSUMER REPORTED FINDING "FOREIGN MATTER" IN THE INDIVIDUAL FOIL PACKAGES. STATED, THERE IS A "SMALL, TAN PIECE OF TAPE" STUCK TO THE SWABS. HE'S FOUND THIS ISSUE IN FEW PACKAGES HE'S OPENED. LOT: 4225004 CATALOG: 326895 DATE OF EVENT: UNKNOWN SAMPLES: YES CL.