BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURECAN SAFETY HUBER NEEDLE

    MDR report key: 1639520 · Received March 18, 2010

    Report

    Report Number
    2523676-2010-00009
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    February 17, 2010
    Report Date
    March 10, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    KGZ
    PMA / PMN Number
    K760385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE REPORTED INCIDENT WAS DISCARDED AND WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE HOUSE RETAINED SAMPLES FOR THE REPORTED LOT WERE SUBJECTED TO SIMULATED USE TESTING PER SPECIFICATION. THE SAFETY CLIP ACTIVATED AS THE NEEDLE WAS PULLED FROM THE GREEN BASE PLATE ON EACH OF THE FIVE RETAIN SAMPLES. NO RESISTANCE WAS MET WHEN PULLING THE NEEDLE THROUGH THE PLASTIC BASE. THE CLIP WAS THEN EXAMINED, AND IT WAS DETERMINED THAT THE CLIP ACTIVATED PROPERLY AND PROTECTED THE NEEDLE TIP ON ALL SAMPLES. THE CLIP WAS THEN RESET AND ACTIVATED SEVERAL MORE TIMES AND THE CLIPS WERE AGAIN NOTED TO COVER THE TIPS OF THE NEEDLES WITHOUT DIFFICULTY, AND REMAINED SECURE ON THE NEEDLE TIP. THE REPORTED INCIDENT COULD NOT BE DUPLICATED. THE DIRECTIONS ON THE PACKAGE STATE "TO REMOVE THE NEEDLE FROM THE PORT, FIRMLY HOLD DOWN GREEN BASE PLATE AND PULL STRAIGHT UP ON THE HUB GRIP. IT SHOULD BE NOTED THAT THE SURECAN SAFETY HUBER NEEDLE 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. IT SHOULD ALSO BE NOTED THAT THE INSTRUCTIONS FOR USE SUPPLIED WITH THIS PRODUCT CAUTION TO "KEEP HANDS BEHIND THE NEEDLE AT ALL TIMES DURING USE AND DISPOSAL." THERE ARE NO OTHER COMPLAINTS OF THIS NATURE AGAINST THIS CATALOG NUMBER AND REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: NEEDLE STICK INJURY. LAB TECH, REMOVING NEEDLE AFTER BLOOD DRAW, MET RESISTANCE WHEN PULLING NEEDLE THROUGH PLASTIC BASE. WOULD NOT PULL OUT, SO IT WAS FORCEFULLY REMOVED, AND NEEDLE REBOUND AND STUCK LAB TECH IN THE FINGER. CLIP NOT ON TIP OF NEEDLE, PRODUCT WAS DISPOSED OF IN THE SHARPS CONTAINER. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED ALL PROTOCOL BLOODWORK TESTING WAS PERFORMED AND ALL TEST RESULTS ARE NEGATIVE. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURECAN SAFETY HUBER NEEDLE SAFETY HUBER NEEDLE KGZ B. BRAUN MEDICAL, INC. SH1926H 61033894

    Patients

    Seq Age Sex Outcome Treatment
    1 Other