BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE

    MDR report key: 21138370 · Received January 13, 2025

    Report

    Report Number
    2618282-2025-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 30, 2024
    Report Date
    March 12, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    BSP
    UDI-DI
    00382904050795
    PMA / PMN Number
    K210978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TEN SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. NINE 27GA X 3.5¿ NEEDLES WERE FROM BATCH 4183543, THE LOT WITH THE REPORTED ISSUE. OUT OF THE NINE, FOUR NEEDLES WERE UNUSED AND SEALED IN THEIR BLISTER AND FIVE NEEDLES WERE OUT OF THE BLISTERS. ONE 27GA X 3.5¿ UNUSED AND SEALED NEEDLE FOR BATCH 1120615, THE LOT THAT WAS REPORTED TO NOT HAVE THE ISSUE, AND THE INTRODUCER WAS ALSO RECEIVED. IT WAS OBSERVED THAT THE NEEDLES HAD THEIR COMPONENTS (NEEDLE, STYLET AND SHIELD). THE SAMPLES WERE SUBMITTED FOR VISUAL INSPECTION AND TESTING. ONE OF THE OPENED NEEDLES FROM THE REPORTED LOT, 4183543, WAS BENT AT THE TIP OF THE HUB WHICH WAS PREVENTING FULL INSERTION OF THE STYLET; THEREFORE, 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 REPORTED ISSUE WAS DUE TO THE BENT NEEDLE. THE ROOT CAUSE OF THE BENT NEEDLE IS POTENTIALLY RELATED TO HANDLING ISSUES AS THERE WERE NO ISSUES WITH THE UNUSED SAMPLES PROVIDED. AS IT IS EXPLAINED IN THE IFU, CARE SHOULD BE TAKEN TO AVOID NEEDLE DAMAGE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Description of Event or Problem · 0

    NEEDLE STUCK WHEN TRYING TO REMOVE FROM SHEATH (SEE PICTURE). NEEDLE RESISTANCE WHEN TRYING TO INSERT INTO INTRODUCER. SCRATCHING FEELING WHEN REMOVING FROM INTRODUCER WHICH BLUNTS THE NEEDLE. OLD PACKAGING OF 405079 (BATCH: 1120615) DOES NOT HAVE ABOVE PROBLEM, PUT TOGETHER IN BOX FOR REFERENCE AND COMPARISON. 405260 INTRODUCER NEEDLE PUT TOGETHER FOR TESTING SCRATCHING SOUND.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461167 NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP BECTON DICKINSON 4183543 00382904050795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown