BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2630861 · Received May 14, 2012

    Report

    Report Number
    9610825-2012-00089
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Date of Event
    May 15, 2012
    Report Date
    June 13, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). THE FACILITY IS UNSURE OF THE ACTUAL LOT NUMBER INVOLVED IN THE INCIDENT. THE LOT NUMBER WAS POSSIBLY ONE OF THE TWO, LOT #1H29258238 OR LOT #1B20258271 (MFG. DATE 02/20/2011 / EXPIRATION DATE 02/01/2016). THE BATCH MANUFACTURING RECORDS FOR BOTH REPORTED LOT NUMBERS WAS REVIEWED. BATCH RECORD REVIEWS DID NOT REVEAL ANY DISCREPANCIES OR NON CONFORMITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. AT THIS TIME, THE ACTUAL DEVICE IN THE REPORTED INCIDENT WAS NOT YET BEEN RETURNED FOR EVALUATION AND THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL PERTINENT INFORMATION REGARDING THE INVESTIGATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: 4251611-02, LOT #'S 1H29258238, 1B20258271. DATE OF EVENT: (B)(6) 2012. EVENT: NEEDLE STICK INJURY, NO FURTHER DETAILS AVAILABLE - BELIEVES SAFETY SHIELD DID NOT DEPLOY. ONE NEEDLE STICK EVENT, THEY DO NOT KNOW FROM WHICH LOT # IT OCCURRED, POSSIBLY ONE OF THE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 1H29258238

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other