BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION SET: 19 GA

    MDR report key: 14694981 · Received June 15, 2022

    Report

    Report Number
    3006425876-2022-00565
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 1, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    BSO
    UDI-DI
    40801902128407
    PMA / PMN Number
    K140110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE CATHETER WAS REMOVED WITHIN 48HR AFTER FIRST SURGERY AND THE BLOOD CLOT WAS FOUND 40HRS AFTER THE REMOVAL. THERE WAS NO CATHETER DEFECT. BLOOD CLOTS FORMED AT THE PUNCTURE SITE; THE DOCTOR PERFORMED LAMINAR DECOMPRESSION SURGERY WITH BOTH PATIENTS TO STOP THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658386 EPIDURAL CATHETERIZATION SET: 19 GA ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL LLC IPN046378 71F21E1251 40801902128407

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H