BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 1080703 · Received July 11, 2008

    Report

    Report Number
    2523676-2008-00060
    Event Type
    Other
    Date Received
    July 11, 2008
    Date of Event
    April 8, 2008
    Report Date
    July 7, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MFR TO BE EVALUATED. ONE USED 20 GA. INTROCAN SAFETY STYLET WITH THE SAFETY CLIP COVERING THE NEEDLE TIP WAS RETURNED. NO MFG DEFECTS WERE NOTED. ALL APPLICABLE SAFETY CLIP DIMENSIONS THAT WERE ABLE TO BE MEASURED ON THE RETURNED SAMPLE WERE CHECKED AND FOUND TO BE WITHIN THE DESIGN SPECIFICATIONS. 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. THE SAMPLE AND ALL AVAILABLE INFO HAS BEEN PROVIDED TO THE ACTUAL MFR, B. BRAUN MEDICAL INDUSTRIES.

    Description of Event or Problem · 1

    TILE: B. BRAUN NEEDLE. EVENT DESC: "IV SAFETY NEEDLE SHEATH DID NOT COVER TIP OF NEEDLE AFTER RN PERFORMED IV START. THE RN DID RECEIVE A NEEDLE STICK. NEEDLE RETAINED, HOWEVER ON PLACING IN THE CONTAINER, THE NEEDLE DID RETRACT AS WAS ORIGINALLY INTENDED." DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE? NO. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? IV START. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO. OTHER PERTINENT INFO: RN DID REPORT TO OCCUPATIONAL HEALTH OFFICE AFTER NEEDLESTICK. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THE R.N. IS FINE AND ALL PROTOCOL BLOODWORK TESTING TO DATE HAS BEEN NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 7C20258R54

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other