BD SUREPREP¿ CAPILLARY TUBES- PLAIN

Additional Manufacturer Narrative

IN THIS MDR, BECTON, DICKINSON & CO. IN (B)(4) HAS BEEN LISTED AS SAFE-TEC CLINICAL PRODUCTS LLC IS AN OEM MANUFACTURING SITE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD SUREPREP¿ CAPILLARY TUBES- PLAIN THE CUSTOMER OBSERVED LEAKAGE FROM TUBES AFTER CENTRIFUGATION. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS 20-50% LEAKAGE ON CENTRIFUGATION FROM THE ¿SEALED¿ END OF THE CAPILLARY TUBE."

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B.5. ADDITIONAL INFORMATION INDICATES THAT THE EVENT OCCURRED 3 TIMES.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD SUREPREP¿ CAPILLARY TUBES- PLAIN THE CUSTOMER OBSERVED LEAKAGE FROM TUBES AFTER CENTRIFUGATION. THIS EVENT OCCURRED 3 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS 20-50% LEAKAGE ON CENTRIFUGATION FROM THE ¿SEALED¿ END OF THE CAPILLARY TUBE." "DID THEY TRY USING A DIFFERENT CENTRIFUGE AND DID IT WORK? YES. SAME ISSUES 2 OTHER CENTRIFUGES. "

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY THE CUSTOMER COMPLAINT ON PRODUCT 420315, LOT 110521, WAS NOT CONFIRMED. THE CUSTOMER REPORTED THAT THEIR PLAIN SUREPREP CAPILLARY TUBES (CAT. 420315, LOT 110521) HAD A 20-50% LEAKAGE ON CENTRIFUGATION FROM THE ¿SEALED¿ END OF THE CAPILLARY TUBE. AN INVESTIGATION OF THE RETAIN SAMPLES AND THE DEVICE HISTORY RECORD DID NOT SHOW ANY DEFECTS. A REVIEW OF THE RETURNED SAMPLES REVEALED NO DEFECTS. A REVIEW OF PAST COMPLAINTS FOR THIS PRODUCT DOES NOT INDICATE A TREND FOR THIS ISSUE. NO FURTHER ACTION WILL BE TAKEN AS THIS IS AN ISOLATED INCIDENT. BD QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR TRENDING. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD SUREPREP¿ CAPILLARY TUBES- PLAIN THE CUSTOMER OBSERVED LEAKAGE FROM TUBES AFTER CENTRIFUGATION. THIS EVENT OCCURRED 3 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS 20-50% LEAKAGE ON CENTRIFUGATION FROM THE ¿SEALED¿ END OF THE CAPILLARY TUBE." "DID THEY TRY USING A DIFFERENT CENTRIFUGE AND DID IT WORK? YES. SAME ISSUES 2 OTHER CENTRIFUGES. "