BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 12673833 · Received October 21, 2021

    Report

    Report Number
    9617032-2021-01080
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 12, 2021
    Report Date
    September 24, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: "MATERIAL #: 364314. LOT/BATCH #: 1090299. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WHEN THE NURSE WAS PREPARING TO USE THE ARTERIAL BLOOD COLLECTOR TO COLLECT BLOOD, SHE FOUND A FOREIGN BODY IN IT AND DID NOT USE IT. THIS INCIDENT OCCURRED DUE TO THE TIMELY DISCOVERY OF THE NURSE, DID NOT CAUSE SERIOUS INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573998 BD PRESET ARTERIAL BLOOD COLLECTION SYRINGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1090299

    Patients

    Seq Age Sex Outcome Treatment
    1