BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFILTRALONG CATHETER

    MDR report key: 8639207 · Received May 24, 2019

    Report

    Report Number
    9611612-2019-00013
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    April 22, 2019
    Report Date
    June 19, 2019
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSO
    UDI-DI
    14048223016036
    PMA / PMN Number
    K080675
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT TOOK PLACE IN SOUTH KOREA AND HAS BEEN REPORTED BY LOCAL DISTRIBUTOR DONGBANG HEALTHCARE. BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION THIS CASE IS CONSIDERED AS CLOSED. - ATTACHMENT: [COMPLAINT REPORT FOR 146-19.PDF].

    Description of Event or Problem · 0

    IRN# 627_146-19. INITIAL REPORTER´S NARRATIVE: IN ATTEMPT TO REMOVE 001157-10A CATHETER AFTER 2 DAYS OF USE ON A C-SECTION PATIENT, THE DOCTOR NOTICED THAT PART OF THE CATHETER BROKE OFF. THE BROKEN PORTION OF CATHETER IS SCHEDULED TO BE REMOVED.

    Additional Manufacturer Narrative · 1

    INCIDENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED BY LOCAL DISTRIBUTOR DONGBANG HEALTHCARE. CURRENTLY THE DATA PROVIDED IS VERY POOR. AS SOON AS MORE DETAILS BECOME AVAILABLE FURTHER REPORTS WILL BE FILED WITH THE AGENCY.

    Description of Event or Problem · 1

    IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: IN ATTEMPT TO REMOVE 001157-10A CATHETER AFTER 2 DAYS OF USE ON A C-SECTION PATIENT, THE DOCTOR NOTICED THAT PART OF THE CATHETER BROKE OFF. THE BROKEN PORTION OF CATHETER IS SCHEDULED TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432812 INFILTRALONG CATHETER PAIN THERAPY CATHETER BSO PAJUNK GMBH MEDIZINTECHNOLOGIE 001157-10A 1270 14048223016036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other