BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2243522 · Received July 15, 2011

    Report

    Report Number
    9610825-2011-00069
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MED INC. (THE IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE ACTUAL DEVICE IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE ACTUAL MFR FOR FURTHER EVAL. A F/U REPORT WILL BE FILED IF ADD'L PERTINENT INFO BECOMES AVAILABLE. IT SHOULD BE NOTED THAT THE INTROCAN SAFETY IS DESIGNED TO REDUCE THE RISK OF NEEDLESTICK INJURIES. HOWEVER, CDC GUIDELINES AND/OR FACILITY PROTOCOLS SHOULD ALWAYS BE FOLLOWED. SHARPS SHOULD BE DISPOSED OF IMMEDIATELY INTO AN APPROPRIATE SHARPS CONTAINER.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: THE CLIP FAILED TO DEPLOY TO TIP OF NEEDLE- CLIP REMAINED ON SHAFT OF NEEDLE RESULTING IN CLINICIAN RECEIVING NEEDLESTICK TO RIGHT INDEX FINGER- PT HISTORY UNK- FACILITY PROTOCOL FOR NEEDLESTICK INJURY TO BE FOLLOWED. NO SAMPLE AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other