BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESIGN OPTIONS®

    MDR report key: 15281455 · Received August 24, 2022

    Report

    Report Number
    2523676-2022-00427
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    August 10, 2022
    Report Date
    September 23, 2022
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    OGE
    UDI-DI
    04046964313653
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THREE PHOTOS WERE PROVIDED BY THE REPORTED FACILITY FOR EVALUATION. VISUAL EVALUATION OF THE PHOTOS SHOWED LIDSTOCK PACKAGING CONFIRMING THE REPORTED ITEM AND LOT# AND A PARTIAL PIECE OF A USED CATHETER THAT WAS SHEARED AND KNOTTED. PER THE MANUFACTURERS INVESTIGATION THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING APPLICATION. USER WILL BE REFERRED TO THE IFU WHICH STATES, "PRECAUTION: ADVANCING THE CATHETER MORE THAN 5 CM PAST THE NEEDLE TIP MAY INCREASE THE LIKELIHOOD OF KINKING OR KNOTTING. CAUTION: DO NOT WITHDRAW CATHETER THROUGH THE EPIDURAL NEEDLE DUE TO THE POSSIBILITY OF SHEARING OR KINKING THE CATHETER. WHEN REMOVING THE CATHETER, EXCESSIVE FORCE SHOULD NEVER BE APPLIED. IF THE CATHETER BECOMES DIFFICULT TO WITHDRAW, CONSULT STANDARD TEXTBOOKS FOR SPECIFIC TECHNIQUES." REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. 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

    AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE THE INTACT EPIDURAL. THE NEUROSURGEON FOUND A DEFECT IN THE CATHETER SHEATH ON REMOVAL. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163718 DESIGN OPTIONS® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MEDICAL INC. 555110 0061817143 04046964313653

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention