BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 7629321 · Received June 22, 2018

    Report

    Report Number
    9610825-2018-00113
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    May 29, 2018
    Report Date
    July 2, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046964399091
    PMA / PMN Number
    K020785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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) DEVICE HISTORY RECORD REVIEW (DHR): REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN- PROCESS AND FINAL CONTROL INSPECTION. INVESTIGATION RESULTS: RECEIVED 1 USED CONTAMINATED CANNULA HUB OF INTROCAN SAFETY PUR 22G, 0.9X25MM-AP WITHOUT PACKAGING. CAPILLARY HUB WAS NOT RETURNED FOR INVESTIGATION. THE SAFETY CLIP WAS IN AN ENGAGED POSITION. THE RETURNED SAMPLE WAS EXAMINED UNDER A SMARTSCOPE. NO DAMAGES WERE OBSERVED ON THE SAFETY CLIP AND CRIMP AREA ON THE CANNULA. THE SAFETY CLIP WAS NOT DEFORMED. NO ABNORMALITY FOUND IN CRIMPING AREA. SIMULATION FOR CLIP FUNCTION: PUSHED BACK THE SAFETY CLIP TO THE CANNULA HUB. INSERTED THE RETURNED SAMPLE WITH A FRESH CAPILLARY HUB OF G22 TO SIMULATE THE CLIP FUNCTION. AFTER WITHDRAWAL, THE SAFETY CLIP WAS ACTIVATED AND ABLE TO COVER CANNULA TIP. CONCLUSION: THE RETURNED SAMPLE WAS TESTED AND NOT ABNORMALITY OBSERVED. DHR REVIEWED SHOWED NO DEVIATION AND THE COMPLAINT BATCH PASSED CLIP FUNCTIONAL TEST AND VISUAL INSPECTION. COMPLAINT IS NOT CONFIRMED.

    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, 4251628-03, WHICH IS NOT SOLD IN THE UNITED STATES, HOWEVER A SIMILAR ITEM NUMBER, 4251628-02, IS SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.. THE 510(K) HAS BEEN UPDATED TO REFLECT A 510(K) THAT ITEM 4251628-02 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 JAPAN: NEEDLESTICK INJURY (SAFETY CLIP FAILURE)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473408 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG N/A 16M16G8362 04046964399091

    Patients

    Seq Age Sex Outcome Treatment
    1