BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12380293 · Received August 27, 2021

    Report

    Report Number
    3002682307-2021-00446
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    July 29, 2021
    Report Date
    September 24, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 8/12/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BD MATERIAL 3077019 AND 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, BOTH PICTURES AND THE PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETURNED SAMPLE, A SYRINGE WAS OBSERVED WITHOUT ANY SCALE MARKINGS. THE PROCESS USED TO PRINT THE SCALE IS CALLED HOT STAMPING. A STAMP IS HEATED AND USED TO INTERPOSE A SPECIAL BLANK PRINTING FOIL ONTO THE BARREL. THROUGH THE USE OF PRESSURE, THE PRINTING FOIL BECOMES EMBEDDED WITHIN THE BARREL WALL. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM A DEFECTIVE PRINTING FOIL ROLL. THE FOIL DID NOT ACT AS EXPECTED, CAUSING IMPROPER PLACEMENT BETWEEN THE STAMP AND THE BARREL, AND THEREFORE RESULTING IN A MISSING PRINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED SYRINGE 2ML LS 23GA 1-1/4IN DN EMERALD HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AFTER UNPACKING, IT WAS FOUND THAT THE 2ML SYRINGE HAD NO SCALE".

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ZIP: (B)(6). 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 SYRINGE 2ML LS 23GA 1-1/4IN DN EMERALD HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "AFTER UNPACKING, IT WAS FOUND THAT THE 2ML SYRINGE HAD NO SCALE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276675 SYRINGE 2ML LS 23GA 1-1/4IN DN EMERALD PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2011199

    Patients

    Seq Age Sex Outcome Treatment
    1