BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN®

    MDR report key: 21813217 · Received April 10, 2025

    Report

    Report Number
    9610825-2025-00206
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 10, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    BSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER: (B)(4). PREMARKET SUBMISSION # K112515 COMPLAINT PROCESSING DEPARTMENT RECEIVED ONE USED PENCAN BULK NL 0.53 X 103 OUT OF A PENCAN 25GX103MM NRFIT M. L. INT.-EU IN OPEN PACKAGING. THE FOLLOWING INVESTIGATION WERE CONDUCTED: VISUAL INSPECTION: THE RECEIVED USED SAMPLE WAS TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO THE TEST PLAN AND TEST METHOD 102002_DAMAGES. THE USED PENCAN CANNULA IS BROKEN OFF AND BENT APPROX. 51 MM AWAY FROM THE CANNULA HUB. THE BROKEN OFF PART OF THE CANNULA WAS NOT HANDED OVER BY THE CUSTOMER. THE AREA OF THE BREAK FROM THE RAW CANNULA SHOWS THAT THE CANNULA WAS BENT BEFORE THE BREAK. BATCH REVIEW: AFTER CHECKING THE RESPECTIVE DOCUMENTATION OF THE PRODUCTION, SHIFT RECORD, RESULTS OF WORKER SELF-INSPECTION AND IN-PROCESS CONTROL, MACHINE DOCUMENTATION, CLEANING RECORD ETC., NO DEVIATIONS COULD BE IDENTIFIED IN THE MENTIONED TIME PERIOD. SUMMARY AND ASSESSMENT: BECAUSE THE SAMPLE WAS ALREADY USED AND BEND, IT WAS ASSUMED A PROBLEM DURING THE APPLICATION PROCESS OCCURRED. BUT RELATING TO THE DAMAGED/ BROKEN OFF CANNULA, THE TESTED SAMPLE IS NOT WITHIN THE SPECIFICATION. THE DEFECT IS CONSIDERED AS CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRPTION: SPINAL ANESTHESIA PERFORMED UNDER NORMAL CONDITIONS. BONE CONTACT OCCURRED TWICE, REQUIRING THE NEEDLE TO BE WITHDRAWN FOR A NEW PUNCTURE. NEEDLE BREAKAGE WAS OBSERVED, WITH THE ANTERIOR END REMAINING IN PLACE. X-RAY TAKEN WITH ANOTHER NEEDLE IN THE INFERIOR SPACE. ATTEMPT TO WITHDRAW THE NEEDLE WITH FORCEPS USING IMAGE INTENSIFIER SHOWED THE NEEDLE'S POSITION, IN CONTACT WITH THE SPINOUS PROCESS. FAILURE. REMOVAL BY SPINAL SURGEON UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453843 PENCAN® NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP B BRAUN MELSUNGEN AG 4502116N-01 24A10A870M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention