BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN® SAFETY

    MDR report key: 6368478 · Received March 1, 2017

    Report

    Report Number
    9610825-2017-00043
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 7, 2017
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    UDI-DI
    04046963166021
    PMA / PMN Number
    K982805
    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). RECEIVED ONE USED SAMPLE OF INTROCAN SAFETY PUR 22G, 0.9X25MM-AP IN AN OPENED PACKAGING. LOT NUMBER PRINTED ON RETURNED PACKAGE WAS 16L12G8361 AND MATERIAL # 4251628-03. THE CATHETER HUB WAS NOT RETURNED FOR INVESTIGATION. IT WAS OBSERVED THAT THE SAFETY CLIP WAS MISSING. SUMMARY OF ROOT CAUSE ANALYSIS: - TWO SCRATCH LINES ALONG CANNULA BODY TOWARDS CANNULA BEVEL WERE OBSERVED. - THESE SCRATCH LINES SHOWED THE EVIDENCE OF CLIP TRAVEL ALONG THE CANNULA. - CANNULA CRIMPING DIMENSION FOR THE COMPLAINT SAMPLE ARE WITHIN SPECIFICATION. - PRODUCTION HISTORICAL DATA ON CRIMP WIDTH, CLIP PULL OFF FORCE AND CLIP HOLE DIAMETER DOES NOT SHOWED ANY ADVERSE TREND. - ASSEMBLY MACHINE HAS ONLINE VISION SYSTEM TO CONDUCT 100% CHECKING ON RELEVANT CRITICAL DIMENSION OF CANNULA INCLUDING CRIMP WIDTH, CRIMP LENGTH, CLIP DIMENSION, CLIP POSITION AND PRESENT OF CLIP. ALL THE DEFECTIVE PARTS WILL BE AUTOMATICALLY REJECTED BY MACHINE. - IPQC AND FINAL CONTROL ALSO CONDUCTED CLIP FUNCTIONAL TEST AS WELL AS PRODUCT COMPLETENESS CHECK. - SAFETY CLIP DETACHED FROM CANNULA ABLE OT BE S SIMULATED BY TURNING THE CATHETER HUB THEN LIFT UP THE CANNULA IN EXTREME ANGLE DURING CANNULA WITHDRAWAL. - HOWEVER, DURING APPLICATION USER SHOULD REMOVE THE CANNULA BY PULLING CANNULA STRAIGHT BACK WITH A SWIFT, CONTINUOUS MOTION PARALLEL TO THE SKIN (ACCORDING TO IFU). - THE CLIP WAS MISSING AND CATHETER HUB WAS NOT RETURNED FOR FUTHER EVALUATION. - HENCE, THE ROOT CAUSE COULD NOT BE DETERMINED.

    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). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE. DEVICE HISTORY RECORD (DHR) : REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN): THE CLIP WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153194 INTROCAN® SAFETY I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG N/A 16L12G8361 04046963166021

    Patients

    Seq Age Sex Outcome Treatment
    1