BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 20762461 · Received November 22, 2024

    Report

    Report Number
    9617032-2024-01841
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 14, 2024
    Report Date
    November 4, 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

    E1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. INVESTIGATION SUMMARY: "MATERIAL #: 364314; LOT/BATCH #: 3110708. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH HAVING THEIR HEMOGARD CAP ATTACHED, AND NO ISSUES WERE OBSERVED RELATING TO LOOSE HEMOGARD CAP AS ALL SAMPLES MET SPECIFICATIONS. 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 LOOSE HEMOGARD CAP. 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 AFTER DRAWING A BLOOD SAMPLE WITH A BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE THE HEMOGARD CAP DID NOT FIT ON THE HUB OF THE SYRINGE. THE USER PLUGGED THE SYRINGE WITH A DIFFERENT CAP. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2601337 BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3110708 50382903643146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown