BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 30GA 1/2IN

    MDR report key: 18998982 · Received March 28, 2024

    Report

    Report Number
    3002682307-2024-00067
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 5, 2024
    Report Date
    May 24, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    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. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 231107. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE CONSISTED OF THE AFFECTED NEEDLE ATTACHED TO A SYRINGE. THE NEEDLE SAMPLE WAS MICROSCOPICALLY EXAMINED AND WAS FOUND TO BE CLOGGED WITH MEDICATION. BASED ON THE PROVIDED FEEDBACK, IT IS UNDERSTOOD THAT THE PRODUCT WAS NOT CLOGGED BEFORE USE, AS THE MEDICATION WAS DRAWN BUT NOT EXPELLED. THE NEEDLES ARE INSPECTED FOR OCCLUSION AS PART OF THE ROUTINE IN-PROCESS INSPECTIONS AFTER ASSEMBLY. IN CERTAIN CIRCUMSTANCES, THE DRUG USED CAN BECOME DEPOSITED WITHIN THE CANNULA, CAUSING THE NEEDLE TO BLOCK DUE TO CRYSTALLIZATION. OCCLUSION IS MOST LIKELY TO OCCUR IF THE DRUG REMAINS IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME. 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 THE BD NEEDLE 30GA 1/2IN WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: "WE HAVE ENCOUNTERED A PROBLEM WITH YELLOW CANULA 30GX1/2 TWICE: IMPOSSIBLE TO GET THE PRODUCT TO BE INJECTED OUT." LOT 231107 EXP. 2028-10

    Description of Event or Problem · 0

    CUSTOMER REPLY 15-MARCH-2024: NO INJURY TO THE PATIENT. NEEDLE KEPT USED WITHOUT SUCCESS: THE BEVEL NOT EFFICIENT ENOUGH, IMPOSSIBLE TO PRICK THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984622 BD NEEDLE 30GA 1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 231107 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown