BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX EPIDURAL CATHETER

    MDR report key: 11889187 · Received May 26, 2021

    Report

    Report Number
    3012307300-2021-05122
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 9, 2023
    Manufacturer
    NULL
    Product Code
    BSO
    PMA / PMN Number
    K150731
    Adverse Event
    Yes
    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

    THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED: "MW 5101535 - MISSING TIP DID NOT SHOW UP ON X-RAY OR CT SCAN. UNABLE TO LOCATE. NO FOREIGN BODIES IDENTIFIED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EPIDURAL CATHETER WAS REMOVED AND THE BLUE TIP WAS MISSING FROM THE END OF THE CATHETER. THE CATHETER WAS ABLE TO BE EASILY REMOVED WITH NO RESISTANCE. THERE WERE NO ADVERSE EVENTS REPORTED OR ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785640 PORTEX EPIDURAL CATHETER CATHETER, CONDUCTION, ANESTHETIC BSO 4098561

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention