BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2243508 · Received August 18, 2011

    Report

    Report Number
    9610825-2011-00105
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 18, 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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN (B)(4) IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4), AND 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. WHILE NO SPECIFIC CONCLUSIONS CAN BE DRAWN, THE FACILITY REPORT DID INDICATE THAT THE SAFETY CLIP MAY HAVE BECOME STUCK IN THE GAUZE AS THE NURSE WAS DISPOSING OF IT IN THE SHARPS CONTAINER, POSSIBLY CAUSING THE SAFETY CLIP TO NOT RETRACT PROPERLY. FOLLOWING CDC GUIDELINES AND/OR FACILITY PROTOCOLS, SHARPS SHOULD ALWAYS BE IMMEDIATELY DISPOSED INTO AN APPROPRIATE SHARPS CONTAINER. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE ACTUAL MFR FOR FURTHER EVAL. A FOLLOW-UP REPORT WILL BE FILED IF ADD'L PERTINENT INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: NURSE RECEIVED NEEDLE STICK INJURY IN PALM OF HAND. WHEN NURSE WENT TO THROW THE CATHETER INTO THE SHARPS CONTAINER, THE INTROCAN SAFETY HAD BEEN STUCK IN THE GAUZE. THE SAFETY CLIP MUST HAVE BECOME CAUGHT IN THE GAUZE AND THE SAFETY CLIP DID NOT RETRACT PROPERLY. THE NURSE WAS TREATED AT THE OCCUPATIONAL HEALTH CLINIC AND TESTED FOR HIV AND HEP C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 0L09258316

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other