BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE HYPODERMIC NEEDLE 25 1 1/2

    MDR report key: 19559206 · Received June 17, 2024

    Report

    Report Number
    MW5156342
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 12, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS POSITIONED PRONE FOR A RECTAL EXAM, THE SURGEON USED A 25G 1 1/2" NEEDLE TO INJECT LOCAL MEDICATION. AS SHE BEGAN TO REMOVE THE NEEDLE FROM THE GLUEAL REGION, THE NEEDLE BROKE OFF FROM THE HUB, LEAVING THE SHARP NEEDLE ITSELF IN THE TISSUE OF THE REGION. AFTER SEVERAL ATTEMPTS WITH THE C-ARM X-RAY BY THE SURGEON AND TWO OTHER SURGEONS TO LOCATE THE NEEDLE, IT WAS DECIDED TO STOP THE OPERATION AND ORDER A CT SCAN. THE PATIENT WAS TAKEN TO PACU AND ADMITTED TO THE UNIT. HE WAS TAKEN TO SURGERY ON (B)(6) 2024 TO REMOVE THE NEEDLE FROM THE ANTERIOR THIGH REGION, AS NOTED ON THE CT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511850 MEDLINE HYPODERMIC NEEDLE 25 1 1/2 SYRINGE, PISTON FMF MEDLINE INDUSTRIES, LP - NORTHFIELD SYR100257 24CBG742

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H| O