BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPISPIN LOCK

    MDR report key: 25148139 · Received May 12, 2026

    Report

    Report Number
    9611612-2026-00008
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 12, 2026
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    UDI-DI
    04048223133125
    PMA / PMN Number
    K060563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IRN# (B)(4). THIS INCIDENT TOOK PLACE IN ITALY. THE DEFECTIVE PRODUCT IN QUESTION IS STILL BEING SENT FOR EVALUATION, WHICH IS WHY THE FINAL REPORT HAS BEEN DELAYED. THE PROCESS IS CURRENTLY IN PROGRESS; ONCE THE FINAL RESULTS HAVE BEEN DETERMINED, THE FU REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IRN# (B)(4). THIS INCIDENT TOOK PLACE ITALY. DEVICE USED FOR ANALGESIC EPIDURAL DURING LABOR. DIFFICULTY INSERTING THE CATHETER. UPON REMOVAL, A DISTAL BREAKAGE IS OBSERVED. SURGICAL INTERVENTION IS PLANNED TO REMOVE THE TERMINAL FRAGMENT REMAINING IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377071 EPISPIN LOCK EPISPIN LOCK_ANESTHESIA CONDUCTION KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 1556 04048223133125

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other| R