BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA

    MDR report key: 113982 · Received August 13, 1997

    Report

    Report Number
    1710034-1997-00025
    Event Type
    Malfunction
    Date Received
    August 13, 1997
    Date of Event
    July 10, 1997
    Report Date
    July 16, 1997
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD-10-31-38 RESULTS-208-200-VISUAL EXAMINATION REVEALED NO UNUSUAL SIGNS OF DEFECT OR DAMAGE WHICH WOULD HAVE RESULTED DURING THE MFG PROCESS. LEAK TESTING CONFIMRED A HOLE IN THE TUBING. CONCLUSION-79-68-NEEDLE WAS NOT REVMOVED GENTLY AND IN ONE SINGLE MOTION CAUSING EVENT. THERE WAS NO LOT NUMBER ASSOCIATED WITH THE DEVICE. OBSERVATIONS: DEVICE HAS VALVED LUER LOCK ADAPTER ATTACHED TO FEMALE LUER LOCK OF Y ADAPTER. IT ALSO HAS SOME DRIED BLOOD BOTH IN AND ON DEVICE. WING HAS SOME OF TAPE ATTACHED TO IT. VISUALLY, DEVICE APPEARS TO HAVE BEEN ASSEMBLED CORRECTLY. CO HAS NOT TAKEN ANY MEASUREMENTS TO CONFIRM THIS AS IT WOULD REQUIRE DISASSEMBLY OF DEVICE. UPON OPTICAL INVESTIATION CO NOTED THAT 22 GAUGE INTIME APPEARS TO NOT HAVE ANY UNUSUAL SIGNS OF DAMAGE. INDICATIONS OF DEFECTS CO OPTICALLY INSPECTED FOR INCLUDED IMPROPER ASSEMBLY, MIS-MOLDED COMPONENTS, DAMAGED EXTRUSIONS OF PVC EXTENSION TUBING OR CATHETER TUBING. RUBBER INJECTION SITE WAS INTACT AND NOT DEGRADED OR DAMAGED. HOLE LEFT IN PRN INJECTION SITE FROM ASSEMBLY PROCESS APPEARS TO BE EXACTLY CENTERED AND NORMAL LOOKING. NEEDLE AND STYLET ASSEMBLY WERE NOT RETURNED WITH DEVICE. RESULTS AND CONCLUSION: CO DID NOT DETECT ANY UNUSUAL SIGNS OF STRESS FROM EXCESSIVE PULL FORCE TO REMOVE NEEDLE AND STYLET ASSEMBLY. UNFORTUNATELY, NEEDLE AND STYLET ASSEMBLY WAS NOT RETURNED WITH DEVICE. THEREFORE, CO CANNOT INSPECT NEEDLE, AND CANNOT ASCERTAIN WHETHER OR NOT NEEDLE CAUSED NORMAL OR EXCESSIVELY HIGH PULL FORCES. A HOLE IN PVC EXTGENSION TUBING WALL WAS DETECTED AT LOCATION APPROX 1/2 INCH FROM Y APAPTER. HOLE WAS NOT OBVIOUS UNDER OPTICAL INSPECTION USING 10X POWER MAGNIFICATION EYE LOUP. HOLE WAS DETECTED AFTER PRESSURE TEST WITH WATER. CO ATTACHED 20CC SYRINGE TO VALVE ON Y ADAPTER AND USED IT TO PRIME DEVICE WITH WATER. CATHETER TIP WAS OCCLUDED USING HENOSTAT. CO GENTLY PRESSURIZED DEVICE AND IMMEDIATELY SAW VERY SMALL STREAM OF WATER LEAKING FROM PUNCTURE HOLE IN WALL OF PVC EXTENSION TUBING.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO START IV IN A PT, NURSE WAS STUCK IN THE FINGER BY THE NEEDLE. WHEN THE STYLET WAS BEING REMOVED THE NEEDLE CAME THROUGH THE TUBING RESULTING IN A NEEDLE STICK INJURY IN THE LEFT MIDDLE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTIMA PERIPHERAL VENOUS ACCESS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other