BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SUREPREP¿ CAPILLARY TUBES- PLAIN

    MDR report key: 14458891 · Received May 20, 2022

    Report

    Report Number
    1119779-2022-00726
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    March 1, 2022
    Report Date
    August 30, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    GIO
    UDI-DI
    30382904203154
    PMA / PMN Number
    K884623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    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 · 0

    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."

    Description of Event or Problem · 0

    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. "

    Description of Event or Problem · 0

    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. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518475 BD SUREPREP¿ CAPILLARY TUBES- PLAIN TUBE, COLLECTION, CAPILLARY BLOOD GIO BECTON, DICKINSON & CO. (SPARKS) 420315 110521 30382904203154

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown