BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPISPIN NRFIT

    MDR report key: 25252320 · Received May 22, 2026

    Report

    Report Number
    9611612-2026-00010
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 22, 2026
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K060563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IRN# (B)(4) THIS INCIDENT TOOK PLACE IN UK. THE INVESTIGATIONS ARE STILL ONGOING. THE ANALYSIS RESULTS WILL BE TRANSMITTED TO THE AGENCY VIA FOLLOW UP REPORT.

    Description of Event or Problem · 0

    IRN# (B)(4) INCIDENT OCCURRED IN UK. WHILST EPIDURAL CATHETER WAS BEING REMOVED, THERE WAS A SMALL AMOUNT OF RESISTANCE. AROUND 4/5CM OF CATHETER BROKE OFF AND REMAINS INSIDE PATIENT. PATIENT REMAINS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263390 EPISPIN NRFIT EPISPIN NRFIT_ANESTHESIA CONDUCTION KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 1596

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other| R