BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿

    MDR report key: 18847846 · Received March 6, 2024

    Report

    Report Number
    9617032-2024-00290
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 7, 2024
    Report Date
    March 8, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903644150
    PMA / PMN Number
    K022426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 364415. LOT/BATCH #: 3132061. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING 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¿ THE SAMPLE (BLOOD) LEAKED THROUGH THE WALLS OF THE SYRINGE. THE HEALTH CARE WORKER WAS WEARING GLOVES. THERE WAS NO NEED FOR EXPOSURE TESTING OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PRESET¿ THE SAMPLE (BLOOD) LEAKED THROUGH THE WALLS OF THE SYRINGE. THE HEALTH CARE WORKER WAS WEARING GLOVES. THERE WAS NO NEED FOR EXPOSURE TESTING OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111436 BD PRESET¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3132061 50382903644150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown