BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7096513 · Received December 7, 2017

    Report

    Report Number
    1710034-2017-00447
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 13, 2017
    Report Date
    January 26, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL ANALYSIS OBSERVATIONS AND TESTING: RECEIVED ONE USED IAG/BC 22GA CATHETER/ADAPTER ASSEMBLY WITH AN OPENED PACKAGE FROM THE LOT NUMBER 7122832. THE CATHETER/ADAPTER WAS ATTACHED TO TERUMO 2.5 ML SYRINGE. VISUAL/MICROSCOPIC EXAMINATION: OBSERVED A CUT/SLIT IN THE CATHETER TUBING ABOVE THE ADAPTER NOSE. WATER/AIR LEAK TEST: AIR BUBBLES WERE OBSERVED COMING FROM THE AREA OF THE CUT/SLIT. DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 7122832  THE LOT NUMBER WAS BUILT ON AFA LINE 1, FROM MAY 7, 2017 THRU MAY 11, 2017. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. CONCLUSION: THE DEFECT LEAKAGE, AS STATED AS THE REPORTED CODE WAS CONFIRMED WITH THE RETURNED CATHETER/ADAPTER ASSEMBLY. THE CATHETER TUBING LEAKED DURING THE WATER LEAK TEST THROUGH THE CUT/SLIT THAT WAS OBSERVED. A DEFINITE ROOT CAUSE FOR SLIT COULD NOT BE DETERMINED. THE FAILURE COULD POTENTIALLY HAPPEN ON ZONE 1, ZONE 2 OR ZONE 5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, A BD INSYTE" AUTOGUARD" BC SHIELDED IV CATHETER LEAKED AN UNKNOWN DRUG AND BLOOD BETWEEN THE CATHETER AND CATHETER ADOPTER. THE CATHETER WAS REPLACED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874689 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7122832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other