BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27GA 1-1/2IN

    MDR report key: 21421492 · Received February 20, 2025

    Report

    Report Number
    1911916-2025-00132
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 22, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903016298
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP: IT WAS REPORTED THE SOLUTION CAME OUT OF THE SIDES OF THE NEEDLE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PACKAGING BLISTER TOP WEB. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301629, LOT 4033053. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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 AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE 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#: 301629, BATCH NUMBER#: 4033053. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED A PROVIDER HAD TO CHANGE OUT THE NEEDLE 4 TIMES WITH A RECENT PROCEDURE, REPORTING THAT WHEN SHE INJECTED THE MEDICATION, THE SOLUTION CAME OUT OF THE SIDES OF THE NEEDLE VS THE SHARP END WHERE THE HOLE IS AND SHOULD BE DELIVERED. PATIENT DIDN¿T RECEIVE THE MEDICATION AND A SECOND POKE HAD TO BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410332 NEEDLE 27GA 1-1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4033053 30382903016298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown