BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2191992 · Received July 29, 2011

    Report

    Report Number
    9610825-2011-00090
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 29, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN (B)(4) 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 EVALUATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. WHILE NO SPECIFIC CONCLUSIONS CAN BE DRAWN, THE FACILITY REPORT DID INDICATE THAT THE PRODUCT PERFORMED AS INTENDED AND THE SAFETY CLIP PROPERLY DEPLOYED AND COVERED THE NEEDLE TIP. BASED ON THE INFORMATION IN THE FACILITY'S REPORT, IT APPEARS THE CLIP DISENGAGED FROM THE NEEDLE TIP DURING CLEAN UP. FOLLOWING CDC GUIDELINES AND/OR FACILITY PROTOCOLS, SHARPS SHOULD ALWAYS BE IMMEDIATELY DISPOSED INTO AN APPROPRIATE SHARPS CONTAINER. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER FOR FURTHER EVALUATION. A FOLLOW UP REPORT WILL BE FILED IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: INSERTION OF CATHETER, REMOVED STYLET, CLIP HAD DEPLOYED TO TIP, NURSE LAID STYLET DOWN, NURSE PICKED UP SUPPLIES AND RECEIVED NEEDLESTICK INJURY, SITE UNK. CLIP HAD FALLEN DOWN ONTO SHAFT OF NEEDLE. SAMPLE NOT SAVED. FACILITY PROTOCOL FOR NEEDLESTICK INJURY FOLLOWED- NO INFORMATION ON PATIENT PROVIDED. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATES THAT THE CLIP DID DEPLOY AND COVER THE TIP OF THE NEEDLE. THE NURSE THEN PLACED THE NEEDLE DOWN TO FINISH-UP THE PROCEDURE. DURING CLEAN-UP, THE NURSE SCOOPED UP THE NEEDLE AND THE CLIP THEN POPPED DOWN THE SHAFT AND THE NURSE RECEIVED A NEEDLESTICK INJURY. FACILITY PROTOCOL WAS FOLLOWED FOR NEEDLESTICK INJURY. INITIAL BLOOD WORK TESTING FOR THE NURSE CAME BACK NEGATIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other