BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SPINAL (SDD) 25G W/DRUGS

    MDR report key: 15316078 · Received August 29, 2022

    Report

    Report Number
    3012307300-2022-16605
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 13, 2020
    Report Date
    August 29, 2022
    Manufacturer
    NULL
    Product Code
    CAZ
    UDI-DI
    15019517115314
    PMA / PMN Number
    K965017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTION WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. OUR RECORDS SHOW THAT THE SUPPLIED DRUGS COMPONENTS CONTINUE TO MEET POTENCY SPECIFICATIONS. COMPLAINT HISTORY REVIEW DOES NOT INDICATE ANY TRENDS FOR THE DRUG LOT NUMBERS REPORTED IN THIS COMPLAINT. THERE WAS NO SAMPLE THAT WAS RETURNED FOR INVESTIGATION, THEREFORE, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. NO ROOT CAUSE COULD BE DETERMINED SINCE THE COMPLAINT COULD NOT BE CONFIRMED SINCE NO SAMPLES OR PICTURES WERE RECEIVED FOR EVALUATION. NO INFORMATION HAS BEEN PROVIDED TO DATE) THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# 617147.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUSPECT DEVICE WAS UNABLE TO PROVIDE ADEQUATE ANESTHESIA. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143769 PORTEX SPINAL (SDD) 25G W/DRUGS ANESTHESIA CONDUCTION KIT CAZ NEPI-3717-20 3960851 15019517115314

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown