BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13417616 · Received February 1, 2022

    Report

    Report Number
    3002682307-2022-00031
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 12, 2022
    Report Date
    March 4, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301944 AND LOT NUMBER 1911108. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PICTURE SAMPLE WAS PROVIDED; HOWEVER, THROUGH THE QUALITY OF THE ONE PICTURE ALONE, IT WAS NOT POSSIBLE TO IDENTIFY THE ISSUE. AT THIS TIME, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA HAD FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FOUND A WHITE FOREIGN MATTER ON THE NEEDLE OF A 5ML SYRINGE, ".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE S2 5ML 23GA 1-1/4IN BD (B)(4) HAD FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FOUND A WHITE FOREIGN MATTER ON THE NEEDLE OF A 5ML SYRINGE, ".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA HAD FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FOUND A WHITE FOREIGN MATTER ON THE NEEDLE OF A 5ML SYRINGE, "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496861 BD SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1911108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown