BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 877211 · Received July 9, 2007

    Report

    Report Number
    2523676-2007-00035
    Event Type
    Other
    Date Received
    July 9, 2007
    Date of Event
    June 7, 2007
    Report Date
    June 29, 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
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION. SINCE THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION AND THE FACILITY HAS REPORTED THIS INCIDENT WAS RELATED TO A USER PROCEDURAL ERROR, THE EXACT NATURE OF THIS INCIDENT COULD NOT BE DETERMINED. 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. BRAWN MEDICAL INDUSTIRIES.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: SEVERAL INCIDENCES WHERE THE SAFETY CLIP ON THIS PRODUCT DID NOT ENGAGE. ONE INCIDENT OF A NEEDLESTICK INJURY DUE TO THE SAFETY CLIP NOT ENGAGING PROPERLY. ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY INDICATED THAT AFTER FURTHER INVESTIGATION THIS INCIDENT IS BELIEVED TO BE RELATED TO A USER PROCEDURAL ERROR, AND IS NOT RELATED TO THE DEVICE MALFUNCTIONING. THE NURSE WAS RE-TRAINED ON THE PROPER USAGE OF THE PRODUCT. BLOODWORK PROTOCOL TESTING WAS PERFORMED ON THE NURSE AND THE PATIENT AND ALL TESTING PERFORMED WAS NEGATIVE. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 6K03258N24

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other