BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 18076656 · Received November 6, 2023

    Report

    Report Number
    9617032-2023-01590
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 20, 2023
    Report Date
    November 29, 2023
    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

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 364314. LOT/BATCH #: 2102900. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING, EACH DRAWN WITH WATER, AND NO ISSUES WERE OBSERVED RELATING TO 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 MODE LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE SMALL AMOUNT OF BLOOD WAS COMING OUT OF SYRINGE WALL AFTER DRAWING BLOOD GAS FOR A PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A SMALL AMOUNT OF BLOOD WAS FOUND TO BE COMING OUT OF THE SYRINGE WALL AFTER DRAWING BLOOD GAS FOR A PATIENT, AND WAS REPLACED AND USED NORMALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE SMALL AMOUNT OF BLOOD WAS COMING OUT OF SYRINGE WALL AFTER DRAWING BLOOD GAS FOR A PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A SMALL AMOUNT OF BLOOD WAS FOUND TO BE COMING OUT OF THE SYRINGE WALL AFTER DRAWING BLOOD GAS FOR A PATIENT, AND WAS REPLACED AND USED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338837 BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2102900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown