BEUDAMED
    FDA Adverse Event Other Summary report: N

    STIMULONG NANOLINE 19G X 50MM

    MDR report key: 2623680 · Received May 24, 2012

    Report

    Report Number
    9611612-2012-00009
    Event Type
    Other
    Date Received
    May 24, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 24, 2012
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K043130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD AND RELEVANT RAW MATERIAL HISTORY FILES OF THE REPORTED BATCH DID NOT INDICATE RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. AT THIS POINT MFR. ASSUMES INAPPROPRIATE FORCES WERE APPLIED TO THE CATHETER UPON REMOVAL PROVOKING BREAKAGE OF THE TIP. ANY FURTHER INFO WILL BE SENT TO FDA AS SOON AS IT BECOMES AVAILABLE. IF NO FURTHER INFO BECOMES AVAILABLE PAJUNK CONSIDERS THIS FILE AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). FROM CUSTOMER EXPERIENCE REPORT: "THE METALLIC TIP OF THE CATHETER BROKE DURING REMOVAL FROM THE PT ((B)(6) FEMALE) AFTER A KNEE ARTHROPLASTY PROCEDURE AND REMAINED INSIDE HER BODY (INGUINAL AREA ABOVE FEMORAL VEIN). ACCORDING TO THE DOCTOR IT IS PROBABLY DUE TO A MANIPULATION ERROR." FRAGMENT IS LEFT WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULONG NANOLINE 19G X 50MM ANESTHESIA CONDUCTION KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 531156-32A 928

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R