BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10832535 · Received November 12, 2020

    Report

    Report Number
    3002682307-2020-00340
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    September 30, 2020
    Report Date
    January 11, 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

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1903122 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. THE RETAINED SAMPLES WERE EXAMINED AND NO INK PARTICLES OR OTHER DEFECTS WERE OBSERVED WITH THE SYRINGES. BASED ON THE INVESTIGATION FINDINGS, THIS EXACT CAUSE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA HAD FOREIGN MATTER INSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2020-09-30, IT IS FOUND THAT THERE IS BLACK INK INSIDE THE UNOPENED SYRINGE BEFORE USE, SO IT SHOULD BE STOPPED AND REPLACED WITH A NEW SYRINGE.

    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 5ML 23GA 1-1/4IN BD (B)(4) HAD FOREIGN MATTER INSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2020, IT IS FOUND THAT THERE IS BLACK INK INSIDE THE UNOPENED SYRINGE BEFORE USE, SO IT SHOULD BE STOPPED AND REPLACED WITH A NEW SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298952 SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1903122

    Patients

    Seq Age Sex Outcome Treatment
    1