BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 1944096 · Received December 3, 2010

    Report

    Report Number
    3006425876-2010-00086
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER BROKE DURING ITS REMOVAL IN THE MATERNITY WARD. APPROXIMATELY 5 CM REMAINED IN THE EPIDURAL CAVITY (LUMBAR 4) BUT THE SPRING WIRE GUIDE SEEMED TO BE TOTALLY REMOVED. THE MIDWIFE HAD DIFFICULTIES TRYING TO REMOVE THE CATHETER AND AS A RESULT, CALLED THE ANAESTHETIST AND NURSE. THE PATIENT WAS PUT IN FETAL POSITION, THEN THE ANAESTHETIST GRASPED THE CATHETER CLOSE TO THE SKIN AND WAS REMOVING IT MM BY MM WHEN A SUDDEN BREAK OCCURRED. TO DATE, THERE IS NO PHYSICAL DEFICIENCY, NO SENSITIVE DEFICIENCY AND NO PAIN FOR THE PATIENT. THE PATIENT WAS INFORMED AND A SCAN DONE ON (B)(6) 2010 WHICH LOCATED THE TIP OF THE CATHETER. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION SET ANESTHESIA PRODUCTS CAZ ARROW INTERNATIONAL INC ZF0078273

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK