BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN

    MDR report key: 3896927 · Received June 6, 2014

    Report

    Report Number
    2523676-2014-00220
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    BSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): DURING WITHDRAWAL OF THE CANNULA AFTER UNSUCCESSFULLY PUNCTURE, THE CANNULA BROKE OFF INSIDE THE PATIENT. THE BROKEN OFF PIECE REMAINED IN THE TISSUE OF THE PATIENT. THE CANNULA WAS REMOVED BY SURGERY. MFR # 9610825-2014-00220.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333030 PENCAN SPINAL NEEDLE BSP B. BRAUN MELSUNGEN AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other