BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 25GA 3/4IN W/O SILICONE

    MDR report key: 20988881 · Received December 20, 2024

    Report

    Report Number
    1911916-2024-00928
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    December 9, 2024
    Report Date
    January 16, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED THE CYSTOTOME IN OUR CUSTOM PACKS HAVE BEEN COMING WITH A SUB-CYSTOTOME, AND THE WHITE PLASTIC LOOKS LIKE IT MELTED ON THE METAL. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A NEEDLE ASSEMBLY WITH AN EPOXY DRIP OVER ON THE NEEDLE HUB. THE NEEDLE IS BENT AS PART OF THE PROCESSING DONE BY THE DISTRIBUTOR. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EPOXY ON THE NEEDLE HUB COULD OCCUR IF THERE WAS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301670, LOT 3053274. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#: 301670 BATCH NUMBER#: 3053274IT WAS REPORTED BY CUSTOMER THAT THE CYSTOTOME IN OUR CUSTOM PACKS HAVE BEEN COMING WITH SUB CYSTOTOME. TODAY THE WHITE PLASTIC LOOKS LIKE IT MELTED ON METAL. THEY ARE PULLING ONE ON THE SIDE IF THEY SEE THIS. NO HARM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045115 NEEDLE NS 25GA 3/4IN W/O SILICONE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3053274

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown