BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SPINAL (SDD) 25G W/DRUGS

    MDR report key: 15316180 · Received August 29, 2022

    Report

    Report Number
    3012307300-2022-16611
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 1, 2020
    Report Date
    August 29, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    CAZ
    PMA / PMN Number
    K965017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. AS A RESULT OF OBSERVING THE SAMPLE, IT WAS CONFIRMED THAT THE CATHETER WAS BROKEN AND THE CATHETER AROUND THE BROKEN POSITION WAS EXTENDED. WHEN OBSERVED WITH A MICROSCOPE, IT WAS CONFIRMED THAT THE FRACTURE SURFACE WAS CRUSHED INTO AN ELLIPTICAL SHAPE, WHICH CLOSELY RESEMBLED THE TRACE OF FRACTURE CAUSED BY BEING SANDWICHED BETWEEN SHARP BLADES SUCH AS SCISSORS. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE HIGHLY PROBABLE THAT THE CATHETER WAS DAMAGED DUE TO CONTACT WITH SCISSORS DURING USE. UDI IS UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10009406, AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE EPIDURAL CATHETER GOT TORN OFF. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300548 PORTEX SPINAL (SDD) 25G W/DRUGS ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL INTERNATIONAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown