BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX COMBINED SPINAL EPIDURAL ANESTHESIA TRAYS

    MDR report key: 3833401 · Received May 19, 2014

    Report

    Report Number
    2183502-2014-00314
    Event Type
    Injury
    Date Received
    May 19, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SMITHS MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K965017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS PLACED IN USE WITH PATIENT AND THE LOSS OF RESISTANCE SYRINGE COMPONENT WAS NOT PROVIDING PROPER FEEDBACK DURING EPIDURAL PLACEMENT. ACCORDING TO REPORTER, PATIENT RECEIVED DURA PUNCTURE. PATIENT RECEIVED AN EPIDURAL BLOOD PATCH AND WAS GIVE VARIOUS ANALGESIC MEDICATIONS FOR APPROXIMATELY ONE WEEK. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295610 PORTEX COMBINED SPINAL EPIDURAL ANESTHESIA TRAYS CAZ - ANESTHESIA CONDUCTION CAZ SMITHS MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention