BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SP S/SU 25GA TW 3-1/2IN WHITACRE

    MDR report key: 21421491 · Received February 20, 2025

    Report

    Report Number
    2618282-2025-00011
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 30, 2025
    Report Date
    April 17, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    BSP
    UDI-DI
    00382904051389
    PMA / PMN Number
    K210978
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TWO SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON INSPECTION, ONE NEEDLE MET THE EXPECTED SPECIFICATION CHARACTERISTICS, WHILE THE OTHER HAD A BROKEN/MISSING MOLDED HANDLE KEY AND A BROKEN HANDLE OFF THE STYLET. THE REPORTED INCIDENT COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE COULD EITHER BE TRACED TO MANUFACTURING DURING ASSEMBLY OR DURING HANDLING OF THE PRODUCT. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    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.

    Description of Event or Problem · 0

    MATERIAL #:405138. BATCH#:4123754. VERBATIM: AHS MDIP # 2527 RESIDENT WAS PERFORMING A SPINAL ANESTHETIC ON A PATIENT IN THE HOLDING AREA PRIOR TO SURGERY. WHEN THEY REMOVED THE NEEDLE, THEY NOTICED THE STILETTE WAS MISSING. UPON CLOSER INSPECTION, YOU COULD SEE THAT THERE WAS A METAL STUB AT THE BASE OF THE ORANGE HUB BUT THE ~3INCH LONG STILETTE WAS MISSING. A FULL SEARCH WAS PERFORMED AND IT WAS NOT LOCATED. A FLAT PLATE X-RAY WAS PERFORMED AND IT WAS NOT SEEN ON X-RAY, NOR WAS IT SEEN ON CT. AT THIS POINT, PATIENT WAS CLEARED FOR SURGERY AND SURGERY PROCEEDED, DELAYED FROM EARLIER. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT? NONE REPORTED. DELAYED SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410331 NEEDLE SP S/SU 25GA TW 3-1/2IN WHITACRE NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP BECTON DICKINSON 4123754 00382904051389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention