BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7606581 · Received June 15, 2018

    Report

    Report Number
    1710034-2018-00297
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    May 22, 2018
    Report Date
    June 26, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: LOT ANALYSIS. DHR REVIEW WAS PERFORMED ON THE LOT NUMBER 6042643. THE PACKAGE WAS MANUFACTURED ON AFA LINE 6 FROM FEBRUARY 12, 2016 THRU FEBRUARY 14, 2016 AND PACKAGED ON PACKAGING LINE 11 FROM FEBRUARY 19, 2016 THRU FEBRUARY 21, 2016. REVIEW OF THE DHR¿S REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND 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. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED 29 UNUSED IAG 14GA UNIT IN PARTIALLY OPENED PACKAGE FROM THE LOT NUMBER 6042643. VISUAL/MICROSCOPIC EXAMINATION: FIVE OF THE PACKAGES WERE PARTIALLY OPENED AT BOTH END OF THE BLISTER PACK. SEVEN OF THE PACKAGES WERE PARTIALLY OPENED AT THE TOP OF THE BLISTER PACK. 13 OF THE PACKAGES WERE PARTIALLY OPENED AT THE BOTTOM OF THE BLISTER PACK. THE SEAL WAS NOT COMPROMISED IN FOUR 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 ADHESIVE USED TO SEAL THE TOP AND BOTTOM WEBS IS UV FLUORESCENT. THE ANALYSIS REVEALED AN ADEQUATE TRANSFER (ADHESIVE) FROM THE TOP WEB TO THE BOTTOM WEB. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND TOP WEB ADHESIVE PRESENCE. BOTH OF THESE VARIABLES WERE LOOKED AT DURING THE INVESTIGATION. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES; THE RETURNED UNITS PROVIDED FOR EVALUATION FOR THIS INCIDENT MET THE MANUFACTURING SPECIFICATION REQUIREMENTS IN REGARD TO PACKAGE SEAL INTEGRITY. INVESTIGATION CONCLUSION: THE DEFECT PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE, 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. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: 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. (B)(4) WAS INITIATED TO ADDRESS THE ISSUE OF OPEN SEAL COMPLAINTS.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6) A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGES OF BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER(S) WERE OPENING AND WERE NO LONGER STERILE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446841 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