BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SPINAL (SDD) 25G W/DRUGS

    MDR report key: 15321965 · Received August 30, 2022

    Report

    Report Number
    3012307300-2022-16805
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Report Date
    August 30, 2022
    Manufacturer
    ST PAUL
    Product Code
    CAZ
    PMA / PMN Number
    K965017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10009406, AS A RESULT OF WARNING LETTER CMS# 617147.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON NOTICED A RESISTANCE ISSUE WITH THE PRODUCT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332548 PORTEX SPINAL (SDD) 25G W/DRUGS ANESTHESIA CONDUCTION KIT CAZ ST PAUL 3719225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown