BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPROTTE CANNULA

    MDR report key: 1303797 · Received January 30, 2009

    Report

    Report Number
    9611612-2009-00001
    Event Type
    Other
    Date Received
    January 30, 2009
    Date of Event
    December 10, 2008
    Report Date
    January 30, 2009
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    PMA / PMN Number
    K911260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CANNULAS WERE BENT IN THE PACKAGING DUE TO INAPPROPRIATE TRANSPORTATION OR STORAGE. DEVICE FAILURE LIKE THE REPORTED ONE ARE NOTICED BY USER PRIOR TO USE. NO PT/USER/THIRD PERSON WAS HARMED, NOT EVEN ENDANGERED. NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE AFFECTED DEVICE HISTORY RECORD AND THE RAW MATERIAL HISTORY FILES FOR THE REPORTED BATCH SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. IF NO FURTHER INFO IS AVAILABLE ALLOWING PAJUNK TO DETERMINE THE ROOT CAUSE THE FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 1

    AE TOOK PLACE IN (B)(6). PAJUNK GOT AWARE OF AE JANUARY 14TH 2009. SPROTTE CANNULAS WERE BENT IN PACKAGING. USER NOTICED BEFORE USE/OPENING THE PACKAGING. NO PT INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPROTTE CANNULA NEEDLE, SPINAL ANESTHESIA BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 121151-27A 10/08

    Patients

    Seq Age Sex Outcome Treatment
    1 Other