BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7709448 · Received July 22, 2018

    Report

    Report Number
    1710034-2018-00416
    Event Type
    Malfunction
    Date Received
    July 22, 2018
    Date of Event
    July 2, 2018
    Report Date
    August 28, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825449
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. OUR QUALITY ENGINEER INSPECTED THE RETURNED UNIT PROVIDED BY THE FACILITY. BD RECEIVED ONE 18GA INSYTE AUTOGUARD UNIT FROM LOT NUMBER 6173926. ALL COMPONENTS WERE PRESENT AND INTACT. THE UNIT WAS RECEIVED PARTIALLY OPEN THEREFORE CONFIRMING THE REPORTED ISSUE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE SET-UP AND IN PROCESS SAMPLES (INCLUDED BUT NOT LIMITED) BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TESTS WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE MANUFACTURING PACKAGING PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. THE ANALYSIS OF THE TOP WEB ADHESIVE WHERE THE PRODUCT CHARACTERISTICS REQUIRE A SPECIFIC SEAL TRANSFER WAS MET PER SPECIFICATIONS. IN ADDITION, THE PAPER TOP WEB OF THE RETURNED UNITS WERE ANALYZED UNDER A UV LIGHT. THE GLUE USED TO SEAL THE TOP AND BOTTOM WEBS IS UV FLUORESCENT. THIS ANALYSIS REVEALED AN ADEQUATE AMOUNT OF TOP WEB ADHESIVE. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE SEAL TRANSFER/WIDTH AND TOP WEB GLUE. BOTH VARIABLES WERE LOOKED AT DURING THE INVESTIGATION. THE RETURNED UNIT PROVIDED FOR EVALUATION FOR THIS INCIDENT MET THE MANUFACTURING SPECIFICATION REQUIREMENTS. IN CONCLUSION, WHERE THE PACKAGE WAS FOUND PARTIALLY OPENED, THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH (SEAL TRANSFER AND TOP WEB GLUE), MEASURED WITHIN SPECIFICATION. ALTHOUGH THE RETURNED UNIT MET SPECIFICATIONS, A CORRECTIVE ACTION PROJECT HAS BEEN IMPLEMENTED TO ADDRESS THE ISSUE OF INADEQUATE SEALING OF PACKAGES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD BC SHIELDED IV CATHETERS PACKAGING ADHESIVE FAILED, RESULTING IN A STERILITY BREACH. NOTICED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS PACKAGING ADHESIVE FAILED, RESULTING IN A STERILITY BREACH. NOTICED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551332 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6173926 30382903825449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other