BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 918041 · Received September 20, 2007

    Report

    Report Number
    2523676-2007-00079
    Event Type
    Other
    Date Received
    September 20, 2007
    Date of Event
    August 24, 2007
    Report Date
    September 14, 2007
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS DISCARDED AND WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. WITHOUT THE SAMPLE A THOROUGH EVALUATION COULD NOT BE PERFORMED. THERE HAVE BEEN NO OTHER COMPLAINTS AGAINST THE REPORTED LOT OF PRODUCT. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IT SHOULD BE NOTED THAT THE INTROCAN SAFETY 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. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED TO THE ACTUAL MANUFACTURER, B. BRAUN MEDICAL INDUSTRIES.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS SHE STARTED IV AND WHEN WITHDRAWING STYLET THE CLIP DID NOT DEPLOY AND SHE STUCK THE FINGER THAT WAS SECURING THE CATHETER. CUSTOMER DID NOT SAVE SAMPLE, BUT ANOTHER NURSE WAS NEARBY AND SHE SHOWED HER THE UNDEPLOYED CLIP. REPORTS IT WAS ABOUT 3/4 OF THE WAY DOWN THE STYLET. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THAT PROTOCOL BLOOD WORK TESTING WAS PERFORMED. THE FACILITY DECLINED TO RELEASE THE RESULTS OF THE BLOOD WORK TESTING AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 6L2525AW15

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other