BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPISPIN LOCK -CATHETER-

    MDR report key: 9143779 · Received October 2, 2019

    Report

    Report Number
    9611612-2019-00028
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 23, 2019
    Report Date
    October 28, 2019
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    UDI-DI
    14048223009410
    PMA / PMN Number
    K060563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT TOOK PLACE IN GERMANY AND HAS BEEN REPORTED THROUGH GERMAN DISTRIBUTION SUBSIDIARY (B)(4). AS THE RISK OF SHEARING-OFF A CATHETER IS COMMONLY KNOWN AND REFERRED TO IN THE INSTRUCTIONS FOR USE AND AS THIS RISK IS ASSESSED IN THE RISK MANAGEMENT FILE AS WELL AS IN THE CLINICAL DATA EVALUATED THIS FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    IRN# (B)(6). INITIAL REPORTER´S NARRATIVE: CATHETER SHEARED OFF.

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(6) DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE GMBH. CURRENTLY THE DATA IS POOR AND THE DEVICE HAS NOT BEEN RETURNED/ ANALYSED. AS SOON AS FURTHER DATA WILL BE AVAILABLE A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY.

    Description of Event or Problem · 1

    IRN#: (B)(4). INITIAL REPORTER´S NARRATIVE: CATHETER SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942554 EPISPIN LOCK -CATHETER- ANAESTHESIA CONDUCTION KIT, SPINAL-EPIDURAL, CONTINUOUS CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 0021351-30 1111 14048223009410

    Patients

    Seq Age Sex Outcome Treatment
    1 Other