BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX PROLONG CONTINUOUS NERVE BLOCK SET

    MDR report key: 3162059 · Received May 30, 2013

    Report

    Report Number
    2183502-2013-00266
    Event Type
    Injury
    Date Received
    May 30, 2013
    Report Date
    May 29, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K001129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE DEVICE WAS PLACED IN USE FOR APPROXIMATELY 1 WEEK. REPORTER STATED THAT THE DEVICE CATHETER TORE DURING REMOVAL FROM USE AND A 4 CM TIP OF THE CATHETER REMAINED. ACCORDING TO REPORTER THE TREATING FACILITY PERFORMED AN MRI EXAMINATION AND DETERMINED NO SURGICAL DEVICE REMOVAL WOULD BE PERFORMED. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238023 PORTEX PROLONG CONTINUOUS NERVE BLOCK SET ANAESTHESIA KIT, BRACHIAL PLEXUS CAZ SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK` Required Intervention