BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN-W FEP

    MDR report key: 15785480 · Received November 11, 2022

    Report

    Report Number
    9610825-2022-00468
    Event Type
    Injury
    Date Received
    November 11, 2022
    Date of Event
    July 21, 2022
    Report Date
    November 11, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K982805
    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 INTERNAL REPORT NUMBER (B)(4). REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 22C05G8911 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. NO SAMPLE RECEIVED FOR EVALUATION. THE SITUATION DESCRIBED AFTER REMOVING THE LEFT RADIAL ARTERY INDWELLING NEEDLE, IT WAS FOUND THAT THE PUNCTURE SOFT NEEDLE WAS BROKEN, THE SOFT NEEDLE CANNULA WAS INCOMPLETE, AND NO BROKEN END WAS FOUND IN THE PUNCTURE SITE. THIS PRODUCT LINE IS ASSEMBLED ON AUTOMATIC ASSEMBLY MACHINES EQUIPPED WITH VISION SYSTEM AND TEST STATIONS. ALONG THE MACHINES, THERE IS 100% CHECKING TO CHECK THE PRESENCE OF CATHETER. DEFECTIVE PARTS WILL BE AUTOMATICALLY REJECTED BY MACHINE. ALL THE PRODUCTS ARE SUBJECTED TO IN-PROCESS QUALITY CONTROLS AND FINAL CONTROLS INSPECTION ON A RANDOM SAMPLE BASIS WHICH HAS BEEN CONDUCTED BY DIFFERENT TEAMS ON A REGULAR BASIS WITHIN THE PRODUCTION PROCESS TO ENSURE THE PRODUCT ARE FREE FROM ANY DAMAGES OR DEFECT. HEREWITH A SYSTEMATIC PRODUCT DEFECT WOULD BE DETECTED. THE PROCESS CARDS SHOWS NO ABNORMALITY FOR THE COMPLAINT BATCH. AS COMMUNICATED IN IFU, WARNING SECTION STATED THAT: · AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM. AS NO SAMPLE WAS RECEIVED, FURTHER EVALUATION WAS NOT POSSIBLE. COMPLAINT IS NOT CONFIRMED. 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

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN CHINA: "BROKEN." "DESCRIPTION OF MALFUNCTION/FAILURE: FRONT END OF NEEDLE BROKE OFF IN PATIENT 'S VESSEL INDICATION:PATIENTS NEED TO USE INDWELLING NEEDLE TO INFUSE LIQUID DURING OPERATION DESCRIPTION OF EVENT:THE PATIENT WAS SENT TO THE RECOVERY ROOM AFTER OPERATION. THE ENDOTRACHEAL TUBE WAS REMOVED AFTER WAKING UP, AND THE LEFT RADIAL ARTERY INDWELLING NEEDLE WAS BROUGHT IN. THE BLOOD GAS EXAMINATION SHOWED NO ABNORMALITY. AFTER REMOVING THE LEFT RADIAL ARTERY INDWELLING NEEDLE, IT WAS FOUND THAT THE PUNCTURE SOFT NEEDLE WAS BROKEN, THE SOFT NEEDLE CANNULA WAS INCOMPLETE, AND NO BROKEN END WAS FOUND IN THE PUNCTURE SITE. THE UPPER SEGMENT OF THE PUNCTURE SITE WAS IMMEDIATELY SQUEEZED TOWARDS THE PUNCTURE SITE, AND NO BROKEN SOFT NEEDLE STUMP WAS FOUND. PRELIMINARY HANDLING OF EVENT:NO BROKEN END WAS FOUND IN THE PUNCTURE SITE. THE PUNCTURE TROCAR WAS SQUEEZED TOWARDS THE PUNCTURE SITE AT THE UPPER SEGMENT OF THE PUNCTURE SITE IMMEDIATELY. NO BROKEN PUNCTURE TROCAR WAS FOUND. THE TOURNIQUET WAS USED TO LIGATE THE UPPER SEGMENT OF THE PUNCTURE SITE. THE HEAD NURSE, DEPARTMENT DIRECTOR AND SURGEON WERE IMMEDIATELY CALLED TO REPORT THAT THE ANESTHESIOLOGIST WENT TO THE BEDSIDE TO CHECK THE PUNCTURE SITE AT THE LEFT SIDE. THE BEDSIDE B ULTRASOUND PHYSICIAN CONFIRMED THAT THE BROKEN END OF THE PUNCTURE SOFT NEEDLE WAS LEFT AT THE LEFT RADIAL ARTERY OF THE PATIENT. THE VASCULAR SURGEON WAS IMMEDIATELY CONSULTED. THE OPERATING ROOM WAS SENT TO CUT THE SKIN OF THE PATIENT 'S ARM UNDER THE GUIDANCE OF B ULTRASOUND TO SUCCESSFULLY FIND THE CORRESPONDING VASCULAR POSITION. THE BROKEN CANNULA SOFT NEEDLE WAS INCISED AND REMOVED. THE PATIENT WAS SENT BACK TO THE DISEASE AFTER THE SUTURE WAS COMPLETED. THE PATIENT HAD NO OBVIOUS DISCOMFORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120435 INTROCAN-W FEP I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG 22C05G8911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown