BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 19255449 · Received May 6, 2024

    Report

    Report Number
    9617032-2024-00697
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 2, 2024
    Report Date
    April 24, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FPA
    UDI-DI
    00382903673643
    PMA / PMN Number
    K212724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. D.2. MEDICAL DEVICE TYPE: ONE ADDITIONAL CODE APPLIES; JKA H.6. INVESTIGATION SUMMARY: "MATERIAL #: 367364 LOT/BATCH #: 3090472 BD RECEIVED FIFTY (50) SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR SPRING POPPING OUT WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. ADDITIONALLY, TEN (10) RETURNED SAMPLES WERE TAKEN AND RETRACTED, NONE OF THE SPRINGS POPPED OUT. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF SPRING POPPING OUT DURING USE. 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. 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 THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE SAFETY MECHANISM FAILED AND THE SPRING INSIDE THE BARREL CAME OUT. NO PATIENT OR USER IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776640 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON, DICKINSON AND COMPANY (BD) 3090472 00382903673643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown