BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7709444 · Received July 22, 2018

    Report

    Report Number
    1710034-2018-00419
    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
    30382903814672
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: 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. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE RETURNED UNITS PROVIDED BY YOUR FACILITY. BD RECEIVED 16 14GA INSYTE AUTOGUARD UNITS FROM LOT NUMBER 6042643. ALL COMPONENTS WERE PRESENT AND INTACT. SOME UNITS WERE RECEIVED PARTIALLY OPEN AND THE REMAINING WERE FOUND NOT OPENED/DAMAGED. 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 UNITS PROVIDED FOR EVALUATION FOR THIS INCIDENT MET THE MANUFACTURING SPECIFICATION REQUIREMENTS. IN CONCLUSION, WHERE SOME OF THE PACKAGES WERE FOUND PARTIALLY OPENED, THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH (SEAL TRANSFER AND TOP WEB GLUE), MEASURED WITHIN SPECIFICATION. ALTHOUGH THE RETURNED UNITS 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¿ 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 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
    551380 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6042643 30382903814672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other