BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 12249548 · Received July 29, 2021

    Report

    Report Number
    3002682307-2021-00366
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 21, 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: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-23. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BD MATERIAL 301942 AND LOT NUMBER 2010172. 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, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, LEAKAGE THROUGH THE PLUNGER ROD COMPONENT WAS OBSERVED. THE SAMPLE WAS THEN EXAMINED WITH MAGNIFICATION AND DAMAGE TO THE PLUNGER ROD LIP COMPONENT WAS DETECTED. THIS TYPE OF DAMAGE MAY BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING FACILITY OR WITHIN THE PLUNGER ASSEMBLY MACHINE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SYRINGE STOPPER WAS LOOSE AND CAUSED FLUID TO LEAK OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE SEAL OF THE SYRINGE STOPPER WAS NOT TIGHT, AND THE MEDICAL STAFF FOUND THE PRODUCT LEAKAGE DURING USE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ SYRINGE STOPPER WAS LOOSE AND CAUSED FLUID TO LEAK OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE SEAL OF THE SYRINGE STOPPER WAS NOT TIGHT, AND THE MEDICAL STAFF FOUND THE PRODUCT LEAKAGE DURING USE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145376 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010172

    Patients

    Seq Age Sex Outcome Treatment
    1