BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPROTTE 2.G

    MDR report key: 10374686 · Received August 6, 2020

    Report

    Report Number
    9611612-2020-00010
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 1, 2020
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    14048223024307
    PMA / PMN Number
    K911202
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT TOOK PLACE IN GERMANY AND HAS BEEN REPORTED THROUGH (B)(4). BASED ON RIK ASSESSMENT AND CLINICAL ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    IRN#: (B)(4). CANNULA IN PATIENT BROKEN.

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6), AND HAS BEEN REPORTED THROUGH (B)(4) 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). CANNULA IN PATIENT BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840256 SPROTTE 2.G SPINAL NEEDLE BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 021251-29A UNKNOWN 14048223024307

    Patients

    Seq Age Sex Outcome Treatment
    1 Other