BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN® SPINAL TRAY

    MDR report key: 5022428 · Received August 21, 2015

    Report

    Report Number
    2523676-2015-00341
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    July 11, 2015
    Report Date
    July 31, 2015
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    BSP
    PMA / PMN Number
    K112515
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE EVENT DESCRIPTION DID INDICATE THAT THERE WAS SOME DIFFICULTLY WITH THE PLACEMENT OF THE NEEDLE. WHILE NO SPECIFIC CONCLUSION CAN BE DRAWN, INCIDENTS OF THIS NATURE CAN GENERALLY OCCUR WHEN THE NEEDLE IS SUBJECTED TO SOME TYPE OF TRAUMA DURING USE THAT STRESSES THE DEVICE BEYOND ITS DESIGN CAPABILITIES. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR NEEDLE MATERIAL NUMBER. THERE WERE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER OF THE NEEDLE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THE NEEDLE BROKE OFF FROM THE HUB WHILE IN THE PATIENT, AND HAD TO BE REMOVED BY SURGERY. THERE WAS NO PATIENT INJURY. THE CRNA HAS USED THIS PRODUCT MULTIPLE TIMES AND IS NOT NEW TO THE PROCEDURE, BUT DID NOTE THAT THIS WAS A DIFFICULT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554472 PENCAN® SPINAL TRAY PENCAN 25 GAUGE SPINAL NEEDLE BSP B. BRAUN MEDICAL INC. P25BK 0061404156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention