BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3111431 · Received April 30, 2013

    Report

    Report Number
    9610825-2013-00115
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MANUFACTURER), AND (B)(4) (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). IN A FOLLOW UP WITH THE FACILITY, THE REPORTER STATED THAT NO SAMPLE WAS AVAILABLE FOR EVALUATION. ADDITIONALLY, HE STATED THAT THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. THE CLINICIAN WAS STUCK WHEN THEY WENT TO GO CLEAN UP THE PACKAGING OF THE NEEDLE FROM THE PATIENT'S BED AFTER STARTING AN IV. THE TIP OF THE NEEDLE CAME OUT FROM THE SIDE OF THE SAFETY CLIP. THE CLINICIAN IS CURRENTLY BEING TESTED EACH MONTH FOR THE NEXT SIX MONTHS FOR POSSIBLE (B)(6). WITHOUT THE ACTUAL SAMPLE, CATALOG ITEM OR LOT NUMBER, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSION CAN BE DRAWN. IT SHOULD BE NOTED THAT THE INTROCAN SAFETY IS DESIGNED TO REDUCE THE RISK OF NEEDLE STICK INJURIES. HOWEVER, CDE GUIDELINES AND/OR FACILITY PROTOCOLS SHOULD ALWAYS BE FOLLOWED. SHARPS SHOULD BE DISPOSED OF IMMEDIATELY INTO AN APPROPRIATE SHARPS CONTAINER. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED TO THE ACTUAL MANUFACTURER, B. BRAUN (B)(4). IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188776 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1