BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD SPROTTE NEEDLE

    MDR report key: 9724718 · Received February 19, 2020

    Report

    Report Number
    9611612-2020-00003
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 30, 2020
    Report Date
    March 9, 2020
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    14048223002428
    PMA / PMN Number
    K911260
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    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 THIS FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    (B)(4). SUMMARIZING TENTATIVE TRANSLATION OF INITIAL REPORTERS NARRATIVE: NEEDLE CAME OFF THE HUB AND HAD TO BE REMOVED USIG SURGICAL CLAMP.

    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

    (B)(4). SUMMARIZING TENTATIVE TRANSLATION OF INITIAL REPORTERS NARRATIVE: NEEDLE CAME OFF THE HUB AND HAD TO BE REMOVED USIG SURGICAL CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191601 STANDARD SPROTTE NEEDLE INTRATHECAL NEEDLE, SINGLE USE BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 321151-31A 1226 14048223002428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention