BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

    MDR report key: 10045714 · Received May 11, 2020

    Report

    Report Number
    3002682307-2020-00151
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    April 14, 2020
    Report Date
    May 22, 2020
    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 SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1901154 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THROUGH EXAMINATION OF THE RETAINED SAMPLES, NO DEFECTS WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED. TAKING INTO ACCOUNT THE CUSTOMER FEEDBACK PROVIDED, IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM AN UNEXPECTED BLOCKAGE IN THE ASSEMBLY MACHINE, HOWEVER, THAT POSSIBILITY CANNOT BE CONFIRMED. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA NEEDLE WAS BENT AND PROTRUDING THROUGH THE SHIELD. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ADDING MEDICINAL SOLUTION TO USE, IT WAS FOUND THAT THE SYRINGE NEEDLE WAS BENT, THE NEEDLE SHIELD WAS DAMAGED OBVIOUSLY, AND THE BENT NEEDLE HAD BEEN PROTRUDING OUTSIDE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA NEEDLE WAS BENT AND PROTRUDING THROUGH THE SHIELD. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ADDING MEDICINAL SOLUTION TO USE, IT WAS FOUND THAT THE SYRINGE NEEDLE WAS BENT, THE NEEDLE SHIELD WAS DAMAGED OBVIOUSLY, AND THE BENT NEEDLE HAD BEEN PROTRUDING OUTSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509138 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1901154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other