BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 19274659 · Received May 8, 2024

    Report

    Report Number
    9617032-2024-00720
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 16, 2024
    Report Date
    April 23, 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

    MATERIAL #: 364314. LOT/BATCH #: 3122762. BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS NOT OBSERVED. THERE IS A LINE IN THE BARREL OF THE SYRINGE THAT IS RECOGNIZED AS A BUILDUP OF THE ADDITIVE. THIS IS AESTHETIC AND DOES NOT IMPACT THE USE OF THE DEVICE. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO FOREIGN MATTER 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE THAT HERE IS A WHITE HORIZONTAL LINE IN THE NEEDLE CAVITY. NO IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548283 BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3122762 50382903643146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown