BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿

    MDR report key: 19393299 · Received May 24, 2024

    Report

    Report Number
    9617032-2024-00796
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 25, 2024
    Report Date
    May 6, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903644150
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: "MATERIAL #: 364415. LOT/BATCH #: 3251818. BD HAD NOT RECEIVED SAMPLES, BUT 6 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DEFORMED PLUNGER STOPPER WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF DEFORMED PLUNGER STOPPER 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 DEFORMED PLUNGER STOPPER. 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 WHILE USING A BD PRESET¿ SYRINGE, THE PLUNGER STOPPER WAS DEFORMED WHICH CAUSED THE BLOOD COLLECTION TO FAIL. THE BLOOD SAMPLE NEEDED TO BE RECOLLECTED. NO IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664450 BD PRESET¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3251818 50382903644150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown