BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN

    MDR report key: 3896919 · Received June 3, 2014

    Report

    Report Number
    2523676-2014-00215
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    CAZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    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)): FIRST NEEDLE WAS BENT. THE ANESTHESIOLOGIST USED ANOTHER NEEDLE ON AN OTHER LEVEL. THE BROKEN PART IS LEFT IN THE MUSCLE OF THE PATIENT. THE NEUROSURGEON AND ANESTHESIOLOGIST LOOKED AT THE POSITION OF THE BROKEN NEEDLE PART AND CONCLUDED THAT THERE IS NO REASON AND RISK AT THIS MOMENT TO REMOVE THIS PART. MFR # 9610825-2014-00215.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325353 PENCAN SPINAL NEEDLE CAZ B. BRAUN MELSUNGEN AG NA 3L14298B21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other