BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 5594124 · Received April 21, 2016

    Report

    Report Number
    9610825-2016-00220
    Event Type
    Malfunction
    Date Received
    April 21, 2016
    Report Date
    April 8, 2016
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K021094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). DEVICE HISTORY RECORD: REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION. INVESTIGATION RESULTS: RECEIVED ONE USED (CONTAMINATED WITH BLOOD) CANNULA HUB OF INTROCAN SAFETY PUR 20G, 1.1X25MM-US WITHOUT PACKAGING. THE CAPILLARY HUB AND PROTECTIVE CAP WERE NOT RETURNED FOR EVALUATION. VISUALLY INSPECTED THE RETURNED SAMPLE AND FOUND THAT THE SAFETY CLIP WAS LOCATED IN THE MIDDLE OF THE CANNULA, NOT IN AN ENGAGED POSITION. THE SAFETY CLIP WAS NOT DEFORMED. THE RETURNED SAMPLE WAS SUBJECTED TO FUNCTIONAL TEST BY REPOSITIONING THE CLIP AND RETESTING WITH A NEW CATHETER HUB (G20) AND FOUND THAT THE CLIP ENGAGED PROPERLY ONTO THE TIP OF THE CANNULA. THERE WAS NO ABNORMALITY FOUND WHILE PULLING THE CATHETER OUT FROM THE CANNULA. THIS INDICATES THAT THERE WAS NO ROUGH SURFACE OR DENTED MARK ALONG THE CANNULA SURFACE THAT WILL PREVENT THE SAFETY CLIP FROM ENGAGING THE CANNULA TIP. BASED UPON THE INVESTIGATION RESULTS, NO SPECIFIC CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL PERTINENT BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: REF # 4251652-02, LOT # 15M19G8306, 1 ITEM, REPORTS CLIP DID NOT DEPLOY WHEN REMOVED NEEDLE FROM CATHETER. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251123 INTROCAN SAFETY IV CANNULAE DQR B.BRAUN MELSUNGEN AG 15M19G8306

    Patients

    Seq Age Sex Outcome Treatment
    1