BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER 22 G X 1 IN.

    MDR report key: 5174379 · Received October 24, 2015

    Report

    Report Number
    1710034-2015-00016
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    October 7, 2015
    Report Date
    December 1, 2015
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION:A SECOND DEVICE EVALUATION WAS PERFORMED BY THE MANUFACTURER SITE ON 11/25/2015. THE EVALUATION CONFIRMED THAT A SEPARATION OCCURRED IN THE CATHETER TUBING AS A RESULT OF A SPEAR THROUGH BY THE CANNULA.

    Additional Manufacturer Narrative · 1

    RESULTS - A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5111723. TWO SAMPLES WERE RETURNED FOR EVALUATION AND WERE INSPECTED UNDER VISUAL/MICROSCOPIC EXAMINATION. ONE UNUSED SAMPLE IN THE ORIGINAL, SEALED PACKAGE WAS RECEIVED. THERE WERE NO BENDS, HOLES, KINKS, SPLITS OR WRINKLES IN THE CATHETER TUBING; NOR THE CHARACTERISTIC V SHAPE OF A SPEAR THROUGH. THE TUBING DID NOT SEPARATE FROM THE ADAPTER WHEN THE NEEDLE WAS RETRACTED. A PULL FORCE TEST WAS PERFORMED AND THE SAMPLE PASSED SPECIFICATION. ONE USED CATHETER/ADAPTER ASSEMBLY WITH AN ATTACHED NEEDLELESS CONNECTOR WAS RECEIVED IN TWO PORTIONS. ON THE PORTION OF THE CATHETER ATTACHED TO ADAPTER, IT WAS OBSERVED THAT THERE WAS APPROXIMATELY ¼ INCH OF CATHETER TUBING PROTRUDING FROM THE NOSE OF THE ADAPTER. THE PIECE OF LOOSE TUBING WAS NOTED TO BE APPROXIMATELY ¾ INCH LONG. THE TUBING EDGES ARE SHARP, JAGGED, AND IN A V SHAPE PATTERN. THE ADAPTER AND THE LOOSE TUBING WERE PIECED BACK TOGETHER AND SHOW THAT THE V SHAPE PATTERNS ALIGN. CONCLUSION- THE REPORTED DEFECT WAS CONFIRMED WITH THE RETURNED UNIT. THE EVIDENCE PROVIDED DOES NOT DELIVER CONFIRMATION THAT THE CATHETER WAS NOT FUNCTIONING CORRECTLY DURING THE PERIOD OF INFUSION. IT IS UNCERTAIN WHETHER THE DEFECT OBSERVED WAS CAUSED BY USE OF SHARP OBJECT OR INSTRUMENT, MANIPULATION OF THE DEVICE PRIOR TO INSERTION, OR BY THE MANUFACTURING PROCESS. THEREFORE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(6). EVALUATION: A DEVICE IS AVAILABLE FOR INVESTIGATION BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WAS PLACED INTRAOPERATIVELY WITHOUT DIFFICULTY BY AN EXPERIENCED ANAESTHETIST. IT WAS NOTED BY THE ICU NURSE 24 HOURS LATER THAT FLUID WAS LEAKING FROM AROUND THE HUB AND UNDER THE DRESSING. THE TAGEDERM DRESSING WAS PEELED BACK TO INSPECT THE INSERTION SITE AND THE IV HUB WAS FOUND SITTING ON THE SKIN WITH THE CANNULA MISSING. THE PATIENT RECEIVED AN X-RAY TO LOCATE THE BROKEN CANNULA. IT WAS FOUND FURTHER UP THE LIMB AND A SURGICAL INCISION UNDER LOCAL ANESTHESIA WAS REQUIRED TO REMOVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703902 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER 22 G X 1 IN. SHIELDED IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5111723

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention