BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIFIX SOFT TIP

    MDR report key: 6169220 · Received December 13, 2016

    Report

    Report Number
    9610825-2016-00893
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K112515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). WE RECEIVED ONE CATHETER. BBAJ INVESTIGATION RESULT: 1. VISUAL INSPECTION THE CATHETER HAS A CUT 15MM FROM THE TIP. SURFACE OF CUT PART HAS A DAMAGE WHICH OCCURRED WHEN CATHETER WAS PULLED FROM NEEDLE.(THAT IS UNDER THE BAN) 2. DIMENSIONS CHECK LENGTH: 1013MM THE OUTER DIAMETER: CUT PART:0.17~1.02MM DAMAGED PART:0.82~0.98MM NO DAMAGED PART:1.04MM (UNUSED CATHETER THE OUTER DIAMETER:1.04MM LENGTH:920MM) 3. TENSILE STRENGTH TEST IT IS WITHIN THE SPECIFICATION RESULT:8.9N (SPEC>5N) THE OCCURED FAILURE IS DUE TO WRONG HANDLING BY THE END USER.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): CATHETER WAS BROKEN AND STAY IN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823247 PERIFIX SOFT TIP EPIDURAL CATHETER DQR B. BRAUN MELSUNGEN AG N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other