BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD WHITACRE HIGH FLOW PENCIL POINT SPINAL NEEDLES, STERILE, SINGLE USE

    MDR report key: 15696053 · Received October 29, 2022

    Report

    Report Number
    2618282-2022-00069
    Event Type
    Injury
    Date Received
    October 29, 2022
    Date of Event
    October 4, 2022
    Report Date
    November 17, 2022
    Manufacturer
    BD CARIBE LTD.
    Product Code
    BSP
    UDI-DI
    00382904051389
    PMA / PMN Number
    K210978
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 19-OCT-2022. H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE NEEDLE WAS OBSERVED TO BE BROKEN. IT WAS NOTED THE STYLET WAS BENT, INDICATING IT WAS REPOSITIONED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR REPORTED LOT 8123892 AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE SAMPLE EVALUATION, IT WAS DETERMINED THIS INCIDENT WAS LIKELY CAUSED DUE TO REPOSITIONING THE NEEDLE DURING USE, THIS ACTION CAN LEAD TO NEEDLE BREAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD WHITACRE HIGH FLOW PENCIL POINT SPINAL NEEDLES, STERILE, SINGLE USE THE NEEDLE BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BROKE OFF IN PATIENT, CT SCAN AND INCISION REQUIRED FOR REMOVAL

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD WHITACRE HIGH FLOW PENCIL POINT SPINAL NEEDLES, STERILE, SINGLE USE THE NEEDLE BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BROKE OFF IN PATIENT, CT SCAN AND INCISION REQUIRED FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703421 BD WHITACRE HIGH FLOW PENCIL POINT SPINAL NEEDLES, STERILE, SINGLE USE ANESTHESIA CONDUCTION NEEDLE BSP BD CARIBE LTD. 8123892 00382904051389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention