BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPROTTE

    MDR report key: 8283976 · Received January 28, 2019

    Report

    Report Number
    9611612-2019-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 22, 2019
    Report Date
    February 19, 2019
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    14048223001438
    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 GERMAN DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE GMBH. BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION FILE THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    IRN# 609_039-18. TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: SECTIO, UNABLE TO GAIN ACCESS TO SPINAL SPACE L3/L4, UPON REMOVAL OF THE NEEDLE WITHOUT STYLET 40MM FROM THE DISTAL END ARE MISSING.

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(4) 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). TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: SECTIO, UNABLE TO GAIN ACCESS TO SPINAL SPACE L3/L4, UPON REMOVAL OF THE NEEDLE WITHOUT STYLET 40MM FROM THE DISTAL END ARE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73352 SPROTTE NEEDLE, ANAESTHESIA CONDUCTION, SPINAL, SINGLE SHOT BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 121151-27A 1260 14048223001438

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R