BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA

    MDR report key: 11234148 · Received January 26, 2021

    Report

    Report Number
    3002682307-2021-00026
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    January 5, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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 1901142. 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. ONE PICTURE SAMPLE WAS RETURNED; HOWEVER, THE PICTURE DID NOT DISPLAY THE PRODUCT RELATED TO THIS REPORTED COMPLAINT. TO FURTHER INVESTIGATE THIS ISSUE, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE INSPECTED AND NO DEFECTS WERE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT ISSUE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE USER FOUND LIQUID LEAKAGE AT THE JOINT OF THE SYRINGE PLASTIC AND STEEL NEEDLE DURING THE USE OF THE PRODUCT."

    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 10ML 22GA 1-1/4IN BD (B)(6) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE USER FOUND LIQUID LEAKAGE AT THE JOINT OF THE SYRINGE PLASTIC AND STEEL NEEDLE DURING THE USE OF THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129832 SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA SYRINGE FMI BECTON DICKINSON, S.A. 1901142

    Patients

    Seq Age Sex Outcome Treatment
    1