BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLE

    MDR report key: 18741748 · Received February 20, 2024

    Report

    Report Number
    3002682307-2024-00031
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    January 29, 2024
    Report Date
    June 4, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    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.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 231105. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. SAMPLES WERE INDICATED AS BEING SHIPPED; UNFORTUNATELY, THE SAMPLE SHIPMENT COULD NOT BE LOCATED BY BD FOR INVESTIGATION. WE APOLOGIZE FOR THIS INCONVENIENCE. IF THE SAMPLE SHIPMENT IS LOCATED, A THOROUGH SAMPLE ANALYSIS WILL BE PERFORMED. AT THIS TIME, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION. THE RETAINED SAMPLES WERE USED TO PUNCTURE A TEST VIAL AND WERE SUBSEQUENTLY EXAMINED. NONE OF THE RETAINED SAMPLES DISPLAYED ANY SIGNS OF BREAKAGE. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. 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 CONVENTIONAL NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: TIP OF THE NEEDLE THAT BREAKS WHEN INJECTING FERINJECT INTO THE INFUSION. THIS IS THE 3RD EVENT THAT HAS OCCURRED WITH THE SAME ISOLATED BATCH.

    Description of Event or Problem · 0

    31-JAN-2024. NO IMPACT ON PATIENTS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398451 BD CONVENTIONAL NEEDLE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 231105

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown