BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPROTTE 2.G

    MDR report key: 9605110 · Received January 20, 2020

    Report

    Report Number
    9611612-2020-00002
    Event Type
    Malfunction
    Date Received
    January 20, 2020
    Date of Event
    January 7, 2020
    Report Date
    February 18, 2020
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    14048223022808
    PMA / PMN Number
    K911202
    Adverse Event
    Yes
    Product Problem
    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 PAJUNK MEDICAL PRODUKTE GMBH. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    (B)(4). INITIAL REPORTER´S NARRATIVE: HUB CAME OFF DURING WITHDRAWAL OF CANNULA.

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(6) DISTRIBUTION SUBSIDIARY (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). INITIAL REPORTER¿S NARRATIVE: HUB CAME OFF DURING WITHDRAWAL OF CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68295 SPROTTE 2.G SPINAL NEEDLE, SINGLE USE BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 121251-27A UNKNOWN 14048223022808

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R