BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 1070758 · Received July 1, 2008

    Report

    Report Number
    2523676-2008-00057
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    May 8, 2008
    Report Date
    June 26, 2008
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE REPORTED INCIDENT HAS NOT YET BEEN MADE AVAILABLE FOR THE MANUFACTURER TO EVALUATE AND A LOT NUMBER WAS NOT REPORTED. WITHOUT THE SAMPLE AND A LOT NUMBER A THOROUGH EVALUATION COULD NOT BE PERFORMED. THERE ARE GENERALLY TWO CAUSES FOR THIS TYPE OF INCIDENT. FIRST, WHILE INSERTING THE CATHETER INTO THE VESSEL, THE NURSE MAY RE-CANNULATE THE STYLET NEEDLE THROUGH THE I.D. OF THE CATHETER AND PERFORATE THE WALL OF THE CATHETER CAUSING A FRACTURE. THE INSTRUCTIONS FOR USE SUPPLIED WITH THE INTROCAN SAFETY STATE THE FOLLOWING: "AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM." SECONDLY, WHEN REMOVING THE TAPE AND/OR DRESSING FROM THE CATHETER INSERTION SITE, A NURSE MAY USE SCISSORS AND INADVERTENTLY CUT THE CATHETER. NEITHER OF THESE PRACTICES, RE-CANNULATING OR USING SCISSORS IN THE AREA OF A CATHETER, ARE RECOMMENDED PRACTICES. WITHOUT THE SAMPLE FOR EVALUATION, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED TO THE ACTUAL MANUFACTURER, B. BRAUN MEDICAL INDUSTRIES. IF THE ACTUAL DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CATHETER INSERTED IN OR IN 2008. PART OF THE CATHETER BROKE OFF DURING REMOVAL THE FOLLOWING DAY. HAS PORTION OF THE CATHETER, APPROXIMATELY 1/2 INCH, AS SAMPLE. FRAGMENT RETRIEVED SURGICALLY. INCIDENT OCCURRED WHILE PATIENT WAS ON THE SURGICAL HEAD & NECK FLOOR. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE PATIENT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT. THE CATHETER FRAGMENT WAS SURGICALLY REMOVED WITHOUT INCIDENT. THE LOT NUMBER REMAINS UNKNOWN SINCE THE CATHETER WAS PLACED IN THE OR. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. THE SAMPLE WILL BE RETURNED 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other