BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 23692869 · Received December 2, 2025

    Report

    Report Number
    9610825-2025-00695
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    October 31, 2025
    Report Date
    January 12, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. NOTE: THIS REPORTED 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. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE USED CERTOFIX CATHETER OUT OF A CERTOFIX TRIO V720 WITHOUT PACKAGING AND ONE CUSTOMER VIDEO OF THE COMPLAINED SAMPLE WERE RECEIVED. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: THE SAMPLE RECEIVED AS WELL AS THE CUSTOMER VIDEO WERE TAKEN TO A VISUAL INSPECTION. THE CONNECTION EXTENSION LINE (MIDDLE) / LLI-CONE (BLUE) ON THE RECEIVED SAMPLE IS LOOSE AND THE EXTENSION LINE CAN EASILY BE PULLED OUT OF THE LLI-CONE BY HAND. THE TUBE IS NOT TORN OFF AND THERE ARE NO TUBE REMNANTS IN THE CONE. THE RECEIVED CUSTOMER VIDEO SHOWS THE COMPLAINED SAMPLE. LEAKAGES OR A DETACHED CONNECTION ARE NOT VISIBLE IN THE VIDEO. PLEASE NOTE: THIS IS NOT A CONNECTION WHERE ADHESIVES ARE USED. THE LLI CONE IS MOLDED DIRECTLY TO THE TUBE. PHYSICAL INSPECTION: THE RECEIVED SAMPLE WAS TAKEN TO A LEAK TEST FOR TIGHTNESS UNDER WATER. LEAKAGES WERE DETECTED IN THE CONNECTION EXTENSION LINE (MIDDLE) / LLI- CONE (BLUE) OF THE SAMPLE. FURTHERMORE, THE RECEIVED SAMPLE WAS TAKEN TO ANOTHER LEAK TEST FOR LIQUID TIGHTNESS. LEAKAGES WERE DETECTED IN THE CONNECTION EXTENSION LINE (MIDDLE) / LLI- CONE (BLUE). PHYSICAL INSPECTION: MOREOVER, THE PIECE OF TUBE FROM THE MIDDLE WAS MEASURED. THE MEASURED VALUE IS WITHIN THE SPECIFICATION. SUMMARY AND ASSESSMENT: THE BATCH HISTORY REVIEW WAS CONDUCTED, AND NO DAMAGES OR ABNORMALITIES WERE IDENTIFIED. RELATING TO THE LOOSE CONNECTION EXTENSION LINE (MIDDLE) / LLI-CONE (BLUE) AND TO THE LEAKAGES IN THE CONNECTION, A PROBLEM DURING THE MANUFACTURING PROCESS CAN BE ASSUMED. BASED ON THE CONDUCTED INVESTIGATIONS, THE TESTED SAMPLE IS NOT WITHIN THE SPECIFICATION. THEREFORE, THE DEFECT IS CONSIDERED AS CONFIRMED. 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 EVENT DESCRIPTION: "DURING THE DEEP VEIN PUNCTURE PROCESS, THE CONNECTION POINT (A TUBE UNDER THE FIXED WING) BROKE, CAUSING PNEUMOTHORAX AND RESPIRATORY DISORDERS ON THE LEFT SIDE OF THE PATIENT. EMERGENCY RESCUE WAS CARRIED OUT, AND THE PATIENT'S CONDITION HAS IMPROVED AND IS STILL RECOVERING.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912347 PERIFIX® CATHETER, CONDUCTION, ANESTHETIC BSO B BRAUN MELSUNGEN AG 25A20A8551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown