BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 14197631 · Received April 25, 2022

    Report

    Report Number
    9617032-2022-00419
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 20, 2022
    Report Date
    April 25, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    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 #: 1162363. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW WATER, AND NO ISSUES WERE OBSERVED RELATING TO DIFFICULT TO MOVE PLUNGER OR LEAKAGE 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 MODES DIFFICULT TO MOVE PLUNGER AND LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES. 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 WHEN USING THE BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, BLOOD FLOW REACHES 0.5ML, THE PISTON OF THE ARTERIAL BLOOD COLLECTION DEVICE CANNOT SLIDE BY ITSELF, SO 1ML BLOOD CAN BE EXTRACTED MANUALLY, AND BLOOD LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿WHEN THE ARTERIAL BLOOD COLLECTION DEVICE IS CONNECTED TO THE BLOOD COLLECTION NEEDLE, BLOOD IS DRAWN SMOOTHLY. WHEN THE ARTERIAL BLOOD FLOW REACHES 0.5ML, THE PISTON OF THE ARTERIAL BLOOD COLLECTION DEVICE CANNOT SLIDE BY ITSELF, SO 1ML BLOOD CAN BE EXTRACTED MANUALLY, AND BLOOD LEAKAGE OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969952 BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1162363

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown