BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 19060582 · Received April 8, 2024

    Report

    Report Number
    9617032-2024-00522
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 8, 2024
    Report Date
    March 19, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FPA
    UDI-DI
    00382903673445
    PMA / PMN Number
    K220212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET. D2B. MEDICAL DEVICE TYPE: JKA H.6. INVESTIGATION SUMMARY: MATERIAL #: 367344. LOT/BATCH #: 3173409. BD RECEIVED 2 SAMPLES AND 1 PHOTO FOR INVESTIGATION. THE SAMPLES AND PHOTO WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR CRACKED LUER ADAPTER WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF CRACKED LUER ADAPTER 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 CRACKED LUER ADAPTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE LEUR ADAPTER CRACKED CAUSING BLOOD LEAKAGE. THIS OCCURRED IN A LARGE QUANTITY OF DEVICES. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121723 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON, DICKINSON AND COMPANY (BD) 3173409 00382903673445

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown