BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURECAN SAFETY HUBER NEEDLE

    MDR report key: 1014113 · Received March 13, 2008

    Report

    Report Number
    2523676-2008-00013
    Event Type
    Other
    Date Received
    March 13, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 29, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FMI
    PMA / PMN Number
    K760385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAFETY HUBER NEEDLE INVOLVED IN THE INCIDENT WAS NOT RETURNED TO THE MFR TO BE EVALUATED. WITHOUT THE SAMPLE A THOROUGH EVAL COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. 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 PROD CAUTION TO "KEEP HANDS BEHIND THE NEEDLE AT ALL TIMES DURING USE AND DISPOSAL."

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: NURSE WAS DE-ACCESSING A PT'S PORTA CATH. AFTER REMOVING THE SURECAN PROD FROM THE PT, THE NURSE WENT TO DISCARD THE PROD INTO THE SHARPS BOX AND THE NEEDLE RUBBED UP AGAINST HER FINGER. NOTED THAT THE SAFETY CLIP WAS NOT ENGAGED AND THE NEEDLE WAS EXPOSED, THE NURSE SUSTAINED A NEEDLESTICK. SAMPLE DISCARDED. NO ADD'L INFO WAS PROVIDED BY THE FACILITY AFTER SEVERAL ATTEMPTS WERE MADE TO THE FACILITY REQUESTING ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURECAN SAFETY HUBER NEEDLE SAFETY HUBER NEEDLE FMI B. BRAUN MEDICAL, INC. NA 60945586

    Patients

    Seq Age Sex Outcome Treatment
    1 Other