BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUOHY NEEDLE

    MDR report key: 10073554 · Received May 20, 2020

    Report

    Report Number
    9611612-2020-00004
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    May 9, 2020
    Report Date
    July 23, 2020
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    14048223004019
    PMA / PMN Number
    K040965
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT TOOK PLACE IN GERMANY AND HAS BEEN REPORTED THROUGH GERMAN DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE GMBH. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    IRN#: (B)(4). TENTATIVE TRANSLATION OF INITIAL REPORTER´S NARRATIVE: WHEN THE CANNULA WAS REMOVED, THE COMPLETE HUB CAME OFF. THE CANNULA TUBE HAD TO BE REMOVED WITH A NEEDLE HOLDER.

    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 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). TENTATIVE TRANSLATION OF INITIAL REPORTER´S NARRATIVE: WHEN THE CANNULA WAS REMOVED, THE COMPLETE HUB CAME OFF. THE CANNULA TUBE HAD TO BE REMOVED WITH A NEEDLE HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539567 TUOHY NEEDLE ANAESTHESIA NEEDLE, EPIDURAL BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 1150-6K091 1330.10 14048223004019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other