BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA

    MDR report key: 10673791 · Received October 13, 2020

    Report

    Report Number
    3002682307-2020-00309
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 7, 2020
    Report Date
    December 16, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-09-29. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1905207 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, THE END OF SOME SCALE MARKINGS AND NUMBERS WERE FOUND TO BE FADED. THE PROCESS USED TO PRINT THE SCALE MARKINGS IS CALLED "HOT STAMPING." A METAL STAMP IS HEATED AND INTRODUCED TO A BLACK PRINTING FOIL. THROUGH PRESSURE THE FOIL IS EMBEDDED FROM THE STAMP INTO THE SYRINGE BARREL WALL. IT HAS BEEN DETERMINED THAT THIS INCIDENT OCCURRED DUE TO A DEFECTIVE BLACK PRINTING FOIL REEL, RESULTING IN AN ABNORMALITY IN THE PRINTING PROCESS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE. 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 10ML 21GA 1-1/2IN BD CHINA HAD SCALE MARKING ISSUES ON 295 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON SEPTEMBER 7, 2020, CHINA RESOURCES RECEIVED FEEDBACK FOR THE PRODUCT 10ML SYRINGE. THE PRODUCT HAS A FUZZY SCALE ISSUE AND CANNOT BE USED NORMALLY AND HOPE TO DEAL WITH IT S.

    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 10ML 21GA 1-1/2IN BD (B)(6) HAD SCALE MARKING ISSUES ON 295 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON SEPTEMBER 7, 2020, (B)(6) RESOURCES RECEIVED FEEDBACK FOR THE PRODUCT 10ML SYRINGE. THE PRODUCT HAS A FUZZY SCALE ISSUE, CANNOT BE USED NORMALLY, AND HOPE TO DEAL WITH IT SERIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134095 SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1905207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other