BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN

    MDR report key: 10398471 · Received August 12, 2020

    Report

    Report Number
    9610825-2020-00174
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 12, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    BSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED PICTURES OF ONE USED PENCAN BULK 0.42X 88 (SP). THE PICTURES WERE CHECKED VISUALLY. RELATING TO THE BROKEN OFF NEEDLE IT IS NOT POSSIBLE TO FIND OUT THE REASON FOR THE DEFECT OF THE COMPLAINT BASED ON THE PICTURES. AS NO SAMPLE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED. THE COMPLAINT IS TAKEN TO KNOWLEDGE AND FILED FOR STATISTICAL PURPOSES. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(4)): THE NEEDLE BROKEN OFF. A VERY DIFFICULT SPINAL PUNCTURE WITH SIGNIFICANT OBESITY FIRST ATTEMPT WITH NEEDLE G27, TO WITHDRAW THE NEEDLE BROKEN OFF, ESTIMATED TO BE A PART OF THE 3.5 CM LONG WITHIN, FURTHERMORE, WITH THE G25, AFTER A NUMBER OF ATTEMPTS TO PROSPER AT THE DEEP PUNCTURE, SPINAL CHANNEL CAN ONLY BE ACHIEVED WITH THE CONTRIBUTION OF FULL-LENGTH OF THE NEEDLE. G27 MEASURE, NEEDLE, PROCEDURE LEVEL, THE DAMAGED MATERIALS REMOVED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863424 PENCAN NEEDLE, CONDUCTION, ANESTH BSP B. BRAUN MELSUNGEN AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention