BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT SYRINGE S2

    MDR report key: 18557834 · Received January 22, 2024

    Report

    Report Number
    3002682307-2024-00009
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    January 4, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903090501
    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

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309050 AND LOT NUMBER 2002170. 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 SAMPLE AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER LIP COMPONENT. ALTHOUGH THE EXACT CAUSE COULD NOT BE DETERMINED FOR THE LEAKAGE, IT MOST LIKELY RESULTED FROM DAMAGE IN THE PLUNGER CAUSED BY 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. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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 BD DISCARDIT SYRINGE S2 LEAKED PAST THE STOPPER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHEN USING THE SYRINGE, ABOUT 2ML CAME UP AT THE PLUNGER. NO PROBLEMS WITH PATIENTS OR NURSING STAFF. THE PRODUCT IS AVAILABLE FOR COLLECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404061 BD DISCARDIT SYRINGE S2 SYRINGE, PISTON FMF BECTON DICKINSON, S.A. 2002170 00382903090501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown