BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 7147955 · Received December 27, 2017

    Report

    Report Number
    1710034-2017-00524
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    November 24, 2017
    Report Date
    January 23, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THREE SAMPLE PACKAGES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, ALL THREE OF THE UNITS WERE OBSERVED TO BE PARTIALLY OPEN AT BOTH ENDS OF THE BLISTER PACKAGING. THE PACKAGES WERE ANALYZED UNDER UV LIGHT AS THE ADHESIVE IS UV FLUORESCENT. THE ANALYSIS REVEALED AN ADEQUATE AMOUNT OF TOP WEB ADHESIVE. ALTHOUGH THE PACKAGES WERE OBSERVED TO BE PARTIALLY OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. PROPER PERSONNEL HAVE BEEN NOTIFIED OF THIS ISSUE FOR FURTHER REVIEW. DHR WAS PERFORMED. THE LOT NUMBER WAS MANUFACTURED ON AFA LINE 4 ((B)(4)) STARTING ON 7 APR 2015 THROUGH 10 APR 2015, AND PACKAGED ON PACKAGING LINE 9 FROM 7 APR 2015 THROUGH 17 JUL 2015 (STOPPED AND RE-STARTED). IN PROCESS SAMPLES (INCLUDED BUT NOT LIMITED) BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TEST WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO RELATED QUALITY NOTIFICATIONS WERE INITIATED. OBSERVATIONS AND TESTING: RECEIVED A TOTAL OF 3 UNUSED PACKAGES FROM LOT NUMBER 5092689. 2 OF THE PACKAGES RECEIVED DID NOT CONTAIN A UNIT WITHIN. VISUAL/MICROSCOPIC EXAMINATION: ALL UNITS RECEIVED WERE PARTIALLY OPEN AT BOTH ENDS OF THE PACKAGES. THE ANALYSIS OF TOP WEB ADHESIVE: THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. THIS CHARACTERISTIC WAS MET. IN ADDITION THE PAPER TOP WEB OF THE RETURNED UNIT WAS ANALYZED UNDER UV LIGHT. THE GLUE USED TO SEAL THE TOP AND BOTTOM WEBS IS UV FLUORESCENT. THE ANALYSIS REVEALED AN ADEQUATE OF TOP WEB ADHESIVE. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND TOP WEB GLUE. BOTH OF THESE VARIABLES WERE LOOKED AT DURING THE INVESTIGATION. THE RETURNED UNITS PROVIDED FOR EVALUATION FOR THIS INCIDENT MET THE MANUFACTURING SPECIFICATION REQUIREMENTS. CONCLUSIONS: THE DEFECT STATED IN THE EVENT DESCRIPTION WAS CONFIRMED WITH THE RETURNED UNITS. EVEN THOUGH THE PACKAGES CAME PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH WERE OBSERVED TO BE WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. THE CUSTOMER EXPERIENCE WAS CONFIRMED BASED ON THE EVALUATION THAT WAS PERFORMED ON THE RETURNED UNITS. THE RELATIONSHIP OF THE DEVICE TO THE REPORTED INCIDENT IS INDETERMINATE. ALTHOUGH THE PACKAGES WERE OBSERVED TO BE PARTIALLY OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. CAPA (B)(4) HAS BEEN OPENED TO INVESTIGATE THE PACKAGE OPEN SEAL DEFECTS AND IMPLEMENT CORRECTIVE ACTIONS. OTHER ACTIONS TAKEN: PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING AND PACKAGING PROCESS WITH PRESCRIBED ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEAL ON THE BD INSYTE AUTOGUARD SHIELDED IV CATHETER WAS OPEN PRIOR TO USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928977 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5092689 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other