BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27GA 1-1/2IN

    MDR report key: 21746710 · Received April 1, 2025

    Report

    Report Number
    1911916-2025-00254
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 11, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED THE NEEDLE BROKE OFF OF THE HUB. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS FIVE PACKAGING BLISTER TOP WEBS. THE SECOND PHOTO SHOWS A NEEDLE HUB ASSEMBLED TO A SYRINGE. THE NEEDLE IS DETACHED FROM THE NEEDLE AND PLACED NEXT TO THE SYRINGE. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301629, LOT 4212478. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    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

    MATERIAL # 301629 BATCH # 4212478. IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE NEEDLE WITH A SYRINGE, THE NEEDLE BROKE OFF OF THE HUB. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT INFORMATION PRODUCT CODE: 301629 PRODUCT DESCRIPTION: NEEDLE HYPO 27 X 1.5IN RB STER BX/100 LOT/SERIAL #: (B)(6) EXPIRY DATE: 2029-09-30. NO ADVERSE EVENT REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579279 NEEDLE 27GA 1-1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4212478

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown