BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESIGN OPTIONS®

    MDR report key: 11805054 · Received May 11, 2021

    Report

    Report Number
    2523676-2021-00113
    Event Type
    Injury
    Date Received
    May 11, 2021
    Report Date
    June 28, 2021
    Product Code
    OGE
    UDI-DI
    04046964843822
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT 1: THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE USED CATHETER WITHOUT PACKAGING WAS RETURNED FOR EVALUATION. VISUAL EVALUATION OF THE SAMPLE SHOWED THE USED CATHETER TO BE STRETCHED, KINKED AND SHEARED. HOWEVER, SINCE IT WAS USED AND INTENTIONALLY PULLED ON/TAMPERED WITH, A THOROUGH INVESTIGATION WAS UNABLE TO BE PERFORMED ON THE RETURNED SAMPLE. PER THE MANUFACTURER`S INVESTIGATION, THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING APPLICATION. USER SHOULD REFER TO IFU WHICH STATES, "NEVER PULL THE CATHETER BACK 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CATHETER BROKE TWICE. EVENT 1 DESCRIPTION: CATHETER BROKE INSIDE A PATIENT. MEDICAL INTERVENTION NECESSARY. CATHETER REMOVAL IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702853 DESIGN OPTIONS® EPIDURAL ANESTHESIA KIT OGE 552101 0061757643 04046964843822

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention