BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18231999 · Received November 29, 2023

    Report

    Report Number
    1024879-2023-00852
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 3, 2023
    Report Date
    December 5, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FPA
    UDI-DI
    00382903673445
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2. ADDITIONAL COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE ADDITIONAL MEDICAL DEVICE TYPE: JKA. G5: ADDITIONAL 510K NUMBER: K220212. H3. 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

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 367344. LOT/BATCH #: 3153459. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR SPLATTER WAS OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL DRAW AND RETRACTION TESTING AND THE ISSUE OF SPLATTER 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. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE SPLATTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD LEAKED FROM THE TIP OF THE NEEDLE WHEN THE USER REMOVED THE NEEDLE FROM THE PATIENT DURING VENIPUNCTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD LEAKED FROM THE TIP OF THE NEEDLE WHEN THE USER REMOVED THE NEEDLE FROM THE PATIENT DURING VENIPUNCTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771710 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON, DICKINSON & CO., (BD) 3153459 00382903673445

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown