BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA

    MDR report key: 11129055 · Received January 7, 2021

    Report

    Report Number
    3002682307-2021-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    October 30, 2020
    Report Date
    April 15, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 1903122. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THROUGH EXAMINATION OF THE RETAINED SAMPLES, NO SIGNS OF FOREIGN MATTER OR DEFECTS WERE OBSERVED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA HAD FOREIGN MATTER IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IMPURITY WAS FOUND IN THE BARREL WHEN IT WAS USED ON OCTOBER 30TH.

    Additional Manufacturer Narrative · 1

    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 5ML 23GA 1-1/4IN BD CHINA HAD FOREIGN MATTER IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IMPURITY WAS FOUND IN THE BARREL WHEN IT WAS USED ON OCTOBER 30TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33133 SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1903122

    Patients

    Seq Age Sex Outcome Treatment
    1