BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11181864 · Received January 15, 2021

    Report

    Report Number
    3002682307-2021-00017
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 15, 2020
    Report Date
    March 19, 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 1901125. 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 SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH INSPECTION OF THE RETAINED SAMPLES, NO DEFECTS WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 2ML 23GA 1-1/4IN BD CHINA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE LIQUID DISPENSING PROCESS, IT WAS FOUND THAT THE 2ML SYRINGE PISTON WAS NOT AIRTIGHT, AND IT WAS EITHER LEAKING OR LEAKING, AND IT COULD NOT BE USED.

    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 CHINA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE LIQUID DISPENSING PROCESS, IT WAS FOUND THAT THE 2ML SYRINGE PISTON WAS NOT AIRTIGHT, AND IT WAS EITHER LEAKING OR LEAKING, AND IT COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77438 SYRINGE S2 2ML 23GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1901125

    Patients

    Seq Age Sex Outcome Treatment
    1