BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN®

    MDR report key: 21970577 · Received May 6, 2025

    Report

    Report Number
    9610825-2025-00259
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    April 7, 2025
    Report Date
    June 25, 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). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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.

    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. NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: DURING A LUMBAR PUNCTURE, UPON REMOVAL OF THE NEEDLE, IT CAME OUT BROKEN, MAKING IT IMPOSSIBLE TO ASSESS ITS LOCATION OR DEPTH. CEREBROSPINAL FLUID (CSF) ANALYSIS NOT PERFORMED, ADDITIONAL SURGERY WAS REPORTED. THERE WERE NO POST-SURGICAL COMPLICATIONS. REPORTEDLY A SCAN WAS CARRIED OUT IN EMERGENCY OF THE LUMBAR SPINE. THE MATERIAL WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67711 PENCAN® NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP B BRAUN MELSUNGEN AG 4502043-13

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention