BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL S/C 200

    MDR report key: 10889617 · Received November 24, 2020

    Report

    Report Number
    1213809-2020-00823
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 28, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0090224; MEDICAL DEVICE EXPIRATION DATE: 2025-03-31; DEVICE MANUFACTURE DATE: 2020-03-30. MEDICAL DEVICE LOT #: 0113963; MEDICAL DEVICE EXPIRATION DATE: 2025-04-30; DEVICE MANUFACTURE DATE: 2020-04-22.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL S/C 200 HAD A BROKEN PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL #: 302995; BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT THE SYRINGE HAD A DEFORMED PLUNGER. VERBATIM: CUSTOMER PROVIDED TWO POSSIBLE LOT #'S ( 0090224 OR 0113963) RN WAS DRAWING UP PRESCRIBED HEPARIN FOR HEMODIALYSIS AND NOTICE A DEFORMED PLUNGER ON THE BD10ML SYRINGE. RN DISCARDED MEDICATION, AND SAVED SYRINGE FOR REPORTING. DID NOT REACH PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363720 SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 SEE SECTION H.10. 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1