BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPISPIN LOCK

    MDR report key: 6197509 · Received December 22, 2016

    Report

    Report Number
    9611612-2016-00162
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    December 18, 2016
    Report Date
    January 13, 2017
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    UDI-DI
    04048223009390
    PMA / PMN Number
    K060563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(6) DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE (B)(4). CURRENTLY THE DATA IS POOR AND THE DEVICE HAS NOT BEEN SENT BACK/ ANALYSED. AS SOON AS FURTHER DATA WILL BE AVAILABLE A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY.

    Additional Manufacturer Narrative · 1

    BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). SUMMARIZING TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE:UPON REMOVAL OF CATHETER AFTER 2 DAYS (48 HOURS) CATHETER RUPTURED/ BROKE OF. FRAGMENT WAS LEFT WITH PATIENT.

    Description of Event or Problem · 1

    (B)(4). SUMMARIZING TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE:UPON REMOVAL OF CATHETER AFTER 2 DAYS (48 HOURS) CATHETER RUPTURED/ BROKE OF. FRAGMENT WAS LEFT WITH PATIENT. PATIENT HAS BEEN INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847598 EPISPIN LOCK CONTINUOUS COMBINED SPINAL EPIDURAL NERVE BLOCK KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 0021351-18 1140 04048223009390

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R