BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 724589 · Received June 7, 2006

    Report

    Report Number
    2523676-2006-00046
    Event Type
    Other
    Date Received
    June 7, 2006
    Date of Event
    April 12, 2006
    Report Date
    May 24, 2006
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SAMPLE CONSISTED OF THE CATHETER HUB WITHOUT THE CATHETER ATTACHED TO THE SPINLOCK CONNECTOR OF AN UNKNOWN IV SET. THE DETACHED CATHETER WAS ALSO RETURNED, LYING LOOSE IN THE BAG. THE INTERNAL STAINLESS STEEL FUNNEL USED TO LOCK THE CATHETER INTO THE HUB COULD CLEARLY BE SEEN AND WAS INTACT. NO PORTION OF THE CATHETER REMAINED INSIDE THE HUB. THE FRACTURED CATHETER APPEARED INTACT. ALTHOUGH THERE IS NO CURRENT, UNUSED INVENTORY OF THE REPORTED POSSIBLE LOTS OF PRODUCT, 25 UNUSED SAMPLES, FROM A LOT CURRENTLY IN B. BRAUN'S INVENTORY WERE SUBJECTED TO A PULL TEST OF THE CATHETER TO HUB JOINT UNTIL FAILURE USING A TENSILE FORCE TESTER. ALL SAMPLES EXCEEDED THE MINIMUM JOINT SEPARATION DESIGN SPECIFICATION AND PASSED THE PULL TEST. THE SAMPLE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED TO THE ACTUAL MANUFACTURER, B. BRAUN MEDICAL INDUSTRIES SDN BHD, IN MALAYSIA.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: WHEN REMOVING CATHETER FROM THE PATIENT THE HUB BROKE OFF. THEY WERE ABLE TO COMPLETELY REMOVE THE CATHETER BEFORE IT MIGRATED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY INDICATED THAT THE CATHETER WAS REMOVED INTACT AND THE PATIENT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA 5M15258W07

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other