BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE IN LAP CHOLE PACK

    MDR report key: 8664540 · Received June 3, 2019

    Report

    Report Number
    1423395-2019-00018
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    FDE
    UDI-DI
    10889942737895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE GAUGE 25 (1.5 INCHES) NEEDLE BROKE OFF INTO PATIENT WHILE INJECTING BUPIVACAINE (LOCAL ANESTHETIC) INTO THE PATIENT'S RIGHT PERI-UMBILICAL REGION. DURING INSPECTION PRIOR TO USE, IT WAS DENIED THAT THERE WERE ANY SIGNS OF MISHANDLING NOTED WITH THE NEEDLE. THE NEEDLE'S SHAFT REPORTEDLY BROKE FROM THE HUB AND THE BROKEN NEEDLE WENT FROM THE UMBILICUS TO THE PSOAS MUSCLE (LOWER LUMBAR REGION), REQUIRING A HOSPITAL STAY AND ANOTHER PROCEDURE. PER REPORT, THE NEXT DAY, THE PATIENT UNDERWENT CT DIRECTED PERCUTANEOUS RETRIEVAL OF THE RETAINED NEEDLE. IT WAS REPORTED THAT THE PATIENT WAS STABLE AND WAS DISCHARGED TO HOME THE DAY AFTER THE INCIDENT. DUE TO THE REPORTED EVENT AND MEDICAL INTERVENTION REQUIRED TO RETRIEVE THE BROKEN NEEDLE, THIS MEDWATCH IS BEING FILED. A COMPANION SAMPLE HAD BEEN RETURNED FOR EVALUATION AND THE COMPLAINT WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GAUGE 25 (1.5 INCHES) NEEDLE BROKE OFF INTO PATIENT WHILE INJECTING LOCAL ANESTHETIC INTO THE PATIENT'S RIGHT PERI-UMBILICAL REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458353 NEEDLE IN LAP CHOLE PACK FDE MEDLINE INDUSTRIES INC. 18KBE366 10889942737895

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R