BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPROTTE

    MDR report key: 7295480 · Received February 26, 2018

    Report

    Report Number
    9611612-2018-00019
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    February 22, 2018
    Report Date
    May 2, 2018
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    14048223000257
    PMA / PMN Number
    K911202
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VENT TOOK PLACE IN GERMANY AND HAS BEEN REPORTED THROUGH GERMAN DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE GMBH. BASED ON RISK MANAGEMENT AND CLINICAL EVALUATION THIS FILE IS CONSIDERED AS CLOSED. ATTACHMENT: [COMPLAINT REPORT FOR 071-18.PDF].

    Description of Event or Problem · 0

    IRN# (B)(4). SUMMARIZING TENTATIVE TRANSLATION OF INITIAL REPORTER´S NARRATIVE: UPON REMOVAL OF THE SPINAL NEEDLE AND THE INTRODUCER THE HUB OF THE INTRODUCER CAME OFF THE NEEDLE.

    Additional Manufacturer Narrative · 1

    VENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(6) DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL (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 REPORTER´S NARRATIVE: UPON REMOVAL OF THE SPINAL NEEDLE AND THE INTRODUCER THE HUB OF THE INTRODUCER CAME OFF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138753 SPROTTE ANAESTHESIA CONDUCTION CANNULA, SPINAL, SINGLE SHOT BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 021151-29A 1125 14048223000257

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R