BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18133676 · Received November 14, 2023

    Report

    Report Number
    1024879-2023-00815
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    March 16, 2021
    Report Date
    November 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FPA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2: COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET D.2. MEDICAL DEVICE TYPE: ONE ADDITIONAL CODE APPLIES: JKA. G5: PMA/510(K)#: ONE ADDITIONAL CODE APPLIES; K220212. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD WAS LEAKING FROM THE DEVICE TUBING ON THE 23-GAUGE BD VACUTAINER BLOOD COLLECTION SETS. THIS EVENT OCCURRED AN UNSPECIFIED NUMBER OF TIMES AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988998 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON, DICKINSON & CO., (BD) UNKNOWN 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown