BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 7916717 · Received September 27, 2018

    Report

    Report Number
    9610825-2018-00203
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Report Date
    July 3, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046964399060
    PMA / PMN Number
    K020785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION. RECEIVED TWO USED CATHETER HUB OF INTROCAN SAFETY FEP 20G, 1.1X45MM-AP IN OPENED PACKAGING. THE CANNULA HUB AND PROTECTIVE CAP WAS NOT RETURNED FOR INVESTIGATION. THE SAMPLE WAS TAKEN FOR INVESTIGATION AND OBSERVED THAT FOR 1 SAMPLE THE CAPILLARY TIP WAS BROKEN OFF ABOUT 30MM FROM CATHETER HORN. THE BROKEN AREA OF THE CAPILLARY EXHIBITS A CLEAR "V" CUT SHAPE. V ISUAL INSPECTION ON THE OTHER SAMPLE DID NOT SHOW ANY BROKEN OFF CAPILLARY. BROKEN OFF CAPILLARY MOST LIKELY NOT APPEAR TO BE ATTRIBUTED BY MANUFACTURING PROCESS AS THE DEFECT IS ABLE TO BE DETECTED AND REJECT BY THE IN-LINE VISION SYSTEM. DAMAGES INDUCED AFTER ASSEMBLY PROCESS IS NOT POSSIBLE SINCE THE CATHETER HAD BEEN PROTECTED WITH PROTECTIVE CAP. BASED ON THE INVESTIGATION, THIS DEFECT IS BELIEVED TO BE CAUSED BY REINSERTING THE CANNULA INTO CAPILLARY WHICH LEAD TO THE CAPILLARY BEING PIERCED AND LATER GOT BROKEN OFF DURING WITHDRAWAL. AS COMMUNICATED IN IFU: WARNING SECTION STATED THAT: · IN THE CASE OF AN UNSUCCESSFUL IV START, REMOVE THE NEEDLE FIRST TO ACTIVATE SAFETY MECHANISM, THEN REMOVE CATHETER FROM PATIENT AND DISCARD BOTH. · AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM. · DO NOT BEND THE CATHETER/NEEDLE DURING INSERTION, ADVANCEMENT, OR REMOVAL OF THE NEEDLE. · EXTREME CARE SHOULD BE TAKEN NOT TO CUT THE CATHETER AND POSSIBLY CAUSE AN EMBOLISM. CAUSE : DEFECT DUE TO WRONG HANDLING

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018. B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THIS FOLLOW UP REPORT IS BEING FILED TO CORRECT THE BRANDING, PRODUCT CODE, AND 510(K) INFORMATION THAT WAS ENTERED ON THE INITIAL MDR IN SECTIONS D1, D2, AND G5. THIS REPORT WAS FILED FOR ITEM NUMBER, 4252527-03, WHICH IS NOT SOLD IN THE UNITED STATES, HOWEVER A SIMILAR ITEM NUMBER, 4252527-02, IS SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.. THE 510(K) HAS BEEN UPDATED TO REFLECT A 510(K) THAT ITEM 4253566-02 HAS BEEN CLEARED UNDER. NOTE: B. BRAUN IS AWARE THAT THE LISTED EXEMPTION HAS BEEN WITHDRAWN, HOWEVER SINCE THE INITIAL MDR REPORT WAS FILED UNDER THIS EXEMPTION, THE FOLLOW UP IS ALSO BEING FILED UNDER THE EXEMPTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN TAIWAN: CATHETER BROKEN OFF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755218 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG N/A 18A07G8244 04046964399060

    Patients

    Seq Age Sex Outcome Treatment
    1