BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 15008410 · Received July 13, 2022

    Report

    Report Number
    3002682307-2022-00180
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    March 20, 2022
    Report Date
    August 1, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309110 AND LOT NUMBER 2110203. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, RETAINED SAMPLES WERE OBTAINED FOR EVALUATION; HOWEVER, THE RETAINED SAMPLES DISPLAYED NO SIGNS OF LEAKAGE. WITH THE LIMITED INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. HOWEVER, BASED ON THE CUSTOMER FEEDBACK, IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY RESULT FROM 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. 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 · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "LIQUID LEAKAGE BETWEEN THE SYRINGE BARREL AND THE PLUNGER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "LIQUID LEAKAGE BETWEEN THE SYRINGE BARREL AND THE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417961 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110203 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown