BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 2ML 23GA 1-1/4IN BD CHINA

    MDR report key: 11335893 · Received February 16, 2021

    Report

    Report Number
    3002682307-2021-00053
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    October 31, 2020
    Report Date
    April 29, 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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1802153. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE EVALUATED AND NO SIGNS OF DEFECT WERE IDENTIFIED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 2ML 23GA 1-1/4IN BD CHINA WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE TOOK OUT THE SYRINGE TO DRAW THE LIQUID MEDICINE WHEN DISPENSING THE MEDICINE, AND FOUND THAT THE SYRINGE¿S WAS BROKEN, AND REPLACED THE SYRINGE AGAIN.

    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 2ML 23GA 1-1/4IN BD (B)(4) WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE TOOK OUT THE SYRINGE TO DRAW THE LIQUID MEDICINE WHEN DISPENSING THE MEDICINE, AND FOUND THAT THE SYRINGES WAS BROKEN, AND REPLACED THE SYRINGE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228751 SYRINGE S2 2ML 23GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1802153

    Patients

    Seq Age Sex Outcome Treatment
    1