BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 8411994 · Received March 12, 2019

    Report

    Report Number
    1917413-2019-00962
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 22, 2019
    Report Date
    March 28, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630801
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO OVERFILL AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE RETAIN PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES ARE OVERFILLING. 10 OF 50 TUBES WERE OVERFILLED. EACH INCIDENT OCCURRED ON 22-FEB. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO. 363080 BATCH NO. 9002613. THE CUSTOMER REPORTED THAT THE TUBES WERE OVERFILLING. JUST RECENTLY BEGAN USING THIS PARTICULAR LOT OF THE BD PRODUCTS AND WE ARE FINDING THAT THE TUBES ARE OVERFILLING BY APPROXIMATELY 250 MICROLITERS. THIS WILL HAVE A NEGATIVE IMPACT ON THE RESULTS PRODUCED BY USING THIS PRODUCT, AND WE WANT TO KNOW IF YOU HAVE BEEN ALERTED BY ANY OTHER CONSUMERS REGARDING THIS ISSUE AND REQUEST THAT WE HAVE SOME CONTACT WITH YOU AS FAR AS REPLACEMENT OF THE PRODUCTS. WE HAVE ABOUT 6 FLATS ON HAND THAT WE HAVE PURCHASES AND WE ARE NEEDING REPLACEMENTS AS URGENTLY AS POSSIBLE. IF YOU CAN GIVE ME A CALL BACK AS EARLY AS MONDAY MORNING. 10 OF 50 TUBES WERE OVERFILLED. DATE OF EVENT FOR EACH INCIDENT WAS 22-FEB. NO REDRAWS AS THEY WERE ALL WITHIN NORMAL RANGE. NO KNOWN ADVERSE EVENTS".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES ARE OVERFILLING. 10 OF 50 TUBES WERE OVERFILLED. EACH INCIDENT OCCURRED ON (B)(6). NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO. 363080 BATCH NO. 9002613. THE CUSTOMER REPORTED THAT THE TUBES WERE OVERFILLING. JUST RECENTLY BEGAN USING THIS PARTICULAR LOT OF THE BD PRODUCTS AND WE ARE FINDING THAT THE TUBES ARE OVERFILLING BY APPROXIMATELY 250 MICROLITERS. THIS WILL HAVE A NEGATIVE IMPACT ON THE RESULTS PRODUCED BY USING THIS PRODUCT, AND WE WANT TO KNOW IF YOU HAVE BEEN ALERTED BY ANY OTHER CONSUMERS REGARDING THIS ISSUE AND REQUEST THAT WE HAVE SOME CONTACT WITH YOU AS FAR AS REPLACEMENT OF THE PRODUCTS. WE HAVE ABOUT 6 FLATS ON HAND THAT WE HAVE PURCHASES AND WE ARE NEEDING REPLACEMENTS AS URGENTLY AS POSSIBLE. IF YOU CAN GIVE ME A CALL BACK AS EARLY AS MONDAY MORNING. 10 OF 50 TUBES WERE OVERFILLED. DATE OF EVENT FOR EACH INCIDENT WAS (B)(6). NO REDRAWS AS THEY WERE ALL WITHIN NORMAL RANGE. NO KNOWN ADVERSE EVENTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205269 BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9002613 50382903630801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other