BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 2ML

    MDR report key: 11233938 · Received January 26, 2021

    Report

    Report Number
    3002682307-2021-00025
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    January 5, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2003184. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE ORIGINALLY FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD. IT HAS BEEN DETERMINED THAT THIS INCIDENT WAS A CONSEQUENCE OF DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE CAN RESULT DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 2ML LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE PAST STOPPER ON A SYRINGE FILLED WITH METHOTREXATE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 2ML LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE PAST STOPPER ON A SYRINGE FILLED WITH METHOTREXATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129682 SYRINGE S2 2ML SYRINGE FMI BECTON DICKINSON, S.A. 2003184

    Patients

    Seq Age Sex Outcome Treatment
    1