BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER 9NC 0.5 ML BLOOD COLLECTION TUBES

    MDR report key: 11917320 · Received June 1, 2021

    Report

    Report Number
    1917413-2021-00460
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    April 30, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM EACH INDICATED LOT FROM THE BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF STOPPER POP OFF WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.5 ML BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED STOPPER POPPING OUT OF THE TUBE. THIS EVENT OCCURRED TEN TIMES WITH LOT 1014067. THIS EVENT OCCURRED TEN TIMES WITH LOT 0352967. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT MAINLY HAPPENS WHEN BLOOD IS TAKEN FROM CATHETERS. WHEN THE TUBE WAS FILLED AND PULLED OUT OF THE HOLDER, THE STOPPER CAME OFF THE TUBE. RISK OF CONTAMINATION WITH BLOOD, BLOOD COLLECTION MUST BE REPEATED.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1014067. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2021-01-14. MEDICAL DEVICE LOT #: 0352967. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2020-12-17. 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 · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.5 ML BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED STOPPER POPPING OUT OF THE TUBE. THIS EVENT OCCURRED TEN TIMES WITH LOT 1014067. THIS EVENT OCCURRED TEN TIMES WITH LOT 0352967. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT MAINLY HAPPENS WHEN BLOOD IS TAKEN FROM CATHETERS. WHEN THE TUBE WAS FILLED AND PULLED OUT OF THE HOLDER, THE STOPPER CAME OFF THE TUBE. RISK OF CONTAMINATION WITH BLOOD, BLOOD COLLECTION MUST BE REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809524 BD VACUTAINER 9NC 0.5 ML BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 0352967

    Patients

    Seq Age Sex Outcome Treatment
    1