BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 19951696 · Received August 9, 2024

    Report

    Report Number
    9610825-2024-00627
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Report Date
    August 9, 2024
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). HC-PM COMPLAINT PROCESSING RECEIVED NO SAMPLE AND NO PICTURE. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: NO SAMPLE WAS RECEIVED AND THUS A FURTHER EVALUATION AND INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE. FUNCTIONAL INSPECTION: N.A. PHYSICAL INSPECTION: N.A. SUMMARY AND ASSESSMENT: AS NO SAMPLE AND NO PICTURE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED AND THEREFORE THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE COMPLAINT IS TAKEN TO KNOWLEDGE AND FILED FOR STATISTICAL PURPOSES. HOWEVER, IF THE COMPLAINT SAMPLE WILL BE PROVIDED, THE COMPLAINT WILL BE RE-OPENED ACCORDINGLY. BECAUSE WE RECEIVED NO BATCH INFORMATION FROM THE CUSTOMER, AN EXAMINATION IS NOT POSSIBLE IF THERE WERE ANY ABNORMALITIES IN THE MANUFACTURING PROCESS OR IN THE CHECK ROUTINE OF THE FINAL CONTROL. THE INVESTIGATION SAMPLE(S) IS/ARE NOT AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT DESCRIPTION: KT EPIDURAL ABLATION WITHOUT RESISTANCE/KT SECTIONED AND REMAINS 2CM IN THE PATIENT'S BACK. NO INDICATION TO REMOVE IT (NO NEUROLOGICAL OR INFECTIOUS SIGNS). NOTE THAT THE INSTALLATION WAS DIFFICULT (2 PUNCTURES INCLUDING 1 WITH SUDDEN MOVEMENT ON THE PART OF THE PATIENT (PAIN) IMAGING TO CLARIFY THE LEVEL AND LOCATION OF THE KT. PART OF THE CATHETER STAYS IN THE PATIENT BODY BUT FOR THE MOMENT NO CONSEQUENCE ON HIS HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201137 PERIFIX® EPIDURAL ANESTHESIA OGE B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown