BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18686808 · Received February 12, 2024

    Report

    Report Number
    9617032-2024-00170
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    January 24, 2024
    Report Date
    January 26, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903673921
    PMA / PMN Number
    K212724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET D2B. MEDICAL DEVICE TYPE: FPA H.6. INVESTIGATION SUMMARY: MATERIAL #: 367392 LOT/BATCH #: 3123394 BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE 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® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THERE WAS BLOOD LEAKAGE AT THE TAIL OF THE BUTTERFLY WING NEEDLE DUE TO A CRACK. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397594 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET SEE H.10 JKA BECTON, DICKINSON AND COMPANY (BD) 3123394 50382903673921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown