APTIMA MULTITEST COLLECTION TUBES
Received May 24, 2017 · Event occurred Mar 24, 2017
Report 2024800-2017-00015 · MDR key 6587710
Device
Product problems
- Defective Component
- Component Missing
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
HOLOGIC DID NOT KNOW THE IMPACT OF THE PILELESS CAPS UNTIL TESTING RESULTS FROM 4/24/2017. THIS REPORT IS SUBMITTED WITHIN 30 DAYS FROM HOLOGIC'S AWARENESS OF POSITIVE TESTING RESULTS. BASED ON THOSE INITIAL RESULTS, ADDITIONAL TESTING WAS REQUIRED TO DETERMINE THE FINAL REPORTABILITY DECISION.
Description of Event or Problem
THE CUSTOMER, (B)(6), REPORTED AN OBSERVATION OF APTIMA MULTITEST COLLECTION TUBES THAT DID NOT CONTAIN THE COTTON LAYER (PILE) WITHIN THE PENETRABLE CAP. THE CUSTOMER CONTINUED ANALYSIS WITH SPECIMEN TUBES FROM AN ALTERNATIVE UNAFFECTED LOT. REVIEW OF THE RETURNED ITEMS REVEALED THAT THE LACK OF A COTTON LAYER IS NOT THE RESULT OF DAMAGE OR MISUSE. THE FOIL SEALS ON THE AFFECTED TUBES RETURNED TO SITE WERE INTACT, AND WHEN OPENED THE COTTON LAYER WAS FOUND TO BE MISSING. IT WAS CONCLUDED THAT THE AFFECTED TUBES HAVE BEEN MANUFACTURED WITH CAPS THAT DID NOT CONTAIN THE COTTON LAYER. IT WAS DETERMINED THE INCORRECT CAP (PN 502212) WAS USED TO MANUFACTURE A SMALL NUMBER OF MUTLTITEST TUBES, PN FFL-00421 LN 184791H.