BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7613500 · Received June 19, 2018

    Report

    Report Number
    1710034-2018-00306
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    May 22, 2018
    Report Date
    June 26, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: THE LOT WAS MANUFACTURED ON LINE 9 FROM AUG 1, 2018 THROUGH AUG 4, 2015 AND PACKAGED ON PACKAGING LINE 11 FROM AUG 5, 2015 THROUGH AUG 6, 2015. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED. OBSERVATIONS AND TESTING: RECEIVED 5 INSYTE AUTOGUARD BC 18GA UNITS FROM LOT NUMBER 5210553 EXP. 2018-07. VISUAL/MICROSCOPIC EXAMINATION: 2 OF THE UNITS WERE PARTIALLY OPEN AT BOTH ENDS. 1 OF THE UNITS WAS PARTIALLY OPEN AT ONE END. 2 OF THE UNITS DID NOT HAVE COMPROMISED SEALING ISSUES. NOTE: THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL WIDTH WITH ADHESIVE TRANSFER FROM THE TOP WEB PAPER TO THE BOTTOM WEB FILM. THIS CHARACTERISTIC WAS MET. IN ADDITION THE PAPER TOP WEB OF THE RETURNED UNITS WAS ANALYZED UNDER UV LIGHT. THE ADHESIVE USED TO SEAL THE TOP AND BOTTOM WEBS IS UV FLUORESCENT. THE ANALYSIS REVEALED ADEQUATE TOP WEB ADHESIVE. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE SEAL TRANSFER/WIDTH AND TOP WEB ADHESIVE PRESENCE. BOTH OF THESE VARIABLES WERE INCLUDED IN THE INVESTIGATION. CONCLUSIONS: THE DEFECT STATED IN THE DESCRIPTION OF THE COMPLAINT WAS CONFIRMED WITH THE RETURNED UNITS. EVEN THOUGH THE PACKAGES WERE PARTIALLY OPENED, ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL WERE OBSERVED TO BE WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. CAPA 48637 WAS INITIATED TO ADDRESS THE ISSUE OF OPEN SEAL COMPLAINTS. TASKS ASSOCIATED WITH THE CAPA PLAN HAVE BEEN COMPLETED.

    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 SEAL ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER APPEARS DEGRADED, PACKETS OPENING SPONTANEOUSLY THEREFORE NO LONGER STERILE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455734 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5210553 30382903825449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other