BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 19104497 · Received April 15, 2024

    Report

    Report Number
    9617032-2024-00567
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 21, 2024
    Report Date
    March 26, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FPA
    UDI-DI
    00382903673926
    PMA / PMN Number
    K212724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 NAME: FPA, JKA. H.6 INVESTIGATION SUMMARY MATERIAL #: 367392. LOT/BATCH #: 3173395 AND 3110642. BD HAD NOT RECEIVED SAMPLES, BUT 1 VIDEO WAS PROVIDED FOR INVESTIGATION. THE VIDEO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR LEAKAGE WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE ISSUE OF LEAKAGE 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 LEAKAGE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET THAT BLOOD WAS FLOWING BACK INTO THE TUBE AND THERE WAS BLOOD LEAKAGE. NO PATIENT IMPACT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470727 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON, DICKINSON AND COMPANY (BD) 3110642 00382903673926

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown