BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 2ML LS 23GA 1-1/4IN

    MDR report key: 12206398 · Received July 21, 2021

    Report

    Report Number
    3002682307-2021-00339
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 7, 2021
    Report Date
    July 6, 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 · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2011199. 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, A PICTURE OF THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, THE SYRINGE WAS OBSERVED WITHOUT ANY SCALE MARKINGS. THE SCALE IS PRINTED ONTO THE SYRINGE THROUGH A PROCESS CALLED ¿HOT STAMPING.¿ A METAL STAMP IS HEATED AND INTERPOSES A SPECIAL BLACK PRINTING FOIL ONTO THE SYRINGE WITH PRESSURE. THE SCALE IS THEN EMBEDDED WITHIN THE BARREL WALL. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED DUE TO A DEFECTIVE FOIL REEL THAT DID NOT WORK AS EXPECTED DURING THE HOT STAMPING PROCESS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 2ML LS 23GA 1-1/4IN EXPERIENCED MISSING SCALE MARKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER OPENING THE 2ML SYRINGE BEFORE SUCKING THE LIQUID, IT WAS FOUND THAT THERE WAS NO SCALE MARKING ON THE SYRINGE TUBE WALL AND IT COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104438 SYRINGE 2ML LS 23GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 2011199

    Patients

    Seq Age Sex Outcome Treatment
    1