BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD ANGIOCATH AUTOGAURD IV CATHETER

    MDR report key: 1420431 · Received May 19, 2009

    Report

    Report Number
    1710034-2009-00092
    Event Type
    Other
    Date Received
    May 19, 2009
    Date of Event
    March 27, 2009
    Report Date
    April 22, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - RECEIVED 10 UNUSED SEALED UNITS, (5) FROM LOT NUMBER 8221114 AND FIVE FROM LOT NUMBER 8162924 FOR THE INVESTIGATION. PERFORMED A VISUAL INSPECTION AND FOUND NO PHYSICAL/MECHANICAL DAMAGE TO THE COMPONENTS. WATER/AIR LEAK TEST WAS ALSO PERFORMED AND OBSERVED NO LEAKAGE AROUND THE CATHETER HUB. WHEN THE BUTTON WAS DEPRESSED, ALL UNITS DID RETRACT ACCORDING TO SPECIFICATION. THE DEVICE HISTORY WAS REVIEWED FOR THE REPORTED LOT NUMBERS AND NO IRREGULARITIES WERE NOTED DURING THE LOT'S MANUFACTURE. CONCLUSIONS: THE ENGINEER CONCLUDED THAT THE INVESTIGATION WAS UNABLE TO CONFIRM FOR CATHETER BROKEN. THE RETURNED SAMPLES DID MEET MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT, ON (B)(6) 2009 IN ICU, THE PATIENT HAD AN ARTERIAL LINE INSERTED. APPROXIMATELY 10 MIN AFTER INSERTION, THE CATHETER WAS FOUND BROKEN AT THE HUB AND REMAINED IN THE PT. THE FOLLOWING DAY A VASCULAR SURGEON REMOVED THE CATHETER FROM THE PT. THE HOSPITAL CLAIMS THAT WHILE THE PT RECOVERED NORMALLY THERE APPEARS TO BE "ABNORMAL HAND MOVEMENT". UPON FURTHER QUESTIONING, IT WAS REVEALED TO BD THAT THIS PATIENT WAS COMBATIVE DURING THE INSERTION AND WAS RESTRAINED WITH WRIST RESTRAINTS OVER THE RADIAL INSERTION SITE. THE PT WAS ALSO "FLEXING" HIS WRIST CONSIDERABLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD ANGIOCATH AUTOGAURD IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 8221114

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other