BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 4071950 · Received August 26, 2014

    Report

    Report Number
    9610825-2014-00323
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 22, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MED, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MFR). THIS REPORT HAS BEEN IDENTIFIED AS (B)(4). RECEIVED ONE CANNULA OF INTROCAN SAFETY PUR 24G, 0.7X19MM-AP WITHOUT PACKAGING. THE CAPILLARY HUB AND PROTECTIVE CAP WAS NOT RETURNED FOR EVALUATION. VISUALLY INSPECTED THE RETURNED SAMPLE AND FOUND THAT THE SAFETY CLIP WAS LOCATED AT APPROXIMATELY 5MM FROM THE CANNULA'S TIP (NOT IN ENGAGED POSITION). REVIEWED THE DEVICE HISTORY RECORD AND THERE WERE NO SUCH DEFECT ENCOUNTERED DURING IN-PROCESS AND FINAL CONTROL INSPECTION. PROCESS CARDS SHOW NO ABNORMALITIES. SAMPLE FORWARDED TO PRODUCTION FOR FURTHER INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY BBM SALES ORGANIZATION IN (B)(4)): THE SAFETY SHIELD DIDN'T AUTOMATICALLY COVER THE NEEDLE TIP AS WITHDRAW NEEDLE EXITED THE CATHETER HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515561 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 4B25258391

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK