BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 20054412 · Received August 23, 2024

    Report

    Report Number
    9617032-2024-01299
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 24, 2024
    Report Date
    July 29, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643146
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: "MATERIAL #: 364314. LOT/BATCH #: 3242324. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF FOREIGN MATTER 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 FOREIGN MATTER. 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 PREPARING TO USE A BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE FOREIGN MATTER WAS FOUND INSIDE THE SYRINGE BARREL. THE DEVICE WAS REPLACED. NO ADVERSE IMPACT TO PATIENTS OR USERS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363706 BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3242324 50382903643146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown