BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18958633 · Received March 22, 2024

    Report

    Report Number
    1024879-2024-00255
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    February 26, 2024
    Report Date
    March 5, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FPA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: MEDICAL DEVICE TYPE: NE ADDITIONAL CODE APPLIES; JKA D2A. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET. G5. PMA / 510(K)#: ONE ADDITIONAL CODE APPLIES: K220212 H.6. INVESTIGATION SUMMARY MATERIAL #: 367342 LOT/BATCH #: 3145421 BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 30 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO DAMAGED SLEEVES OR RETRACTION LOCKOUT AS ALL SAMPLES MET SPECIFICATIONS. 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE SLEEVE FALL OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE RUBBER STOPPER AT THE END OF THE COLLECTION NEEDLE FELL OFF AND NO REPORT OF ADVERSE OR INJURY TO THE PATIENT OR HEALTHCARE WORKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325101 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON, DICKINSON & CO., (BD) 3145421 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown