BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6967037 · Received October 20, 2017

    Report

    Report Number
    1710034-2017-00250
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 25, 2017
    Report Date
    September 29, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7080821; MEDICAL DEVICE EXPIRATION DATE: 2020-02-29; DEVICE MANUFACTURE DATE: 2017-03-23; MEDICAL DEVICE LOT #: 7026572; MEDICAL DEVICE EXPIRATION DATE: 2019-12-31; DEVICE MANUFACTURE DATE: 2017-01-26; MEDICAL DEVICE LOT #: 7048945; MEDICAL DEVICE EXPIRATION DATE: 2020-01-31; DEVICE MANUFACTURE DATE: 2017-02-17. INVESTIGATION: RECEIVED ONE UNUSED IAG 20GA UNIT IN PARTIALLY OPENED PACKAGES FROM EACH LOT NUMBER REPORTED. THE DEFECT THE CUSTOMER EXPERIENCED WAS CONFIRMED BASED ON THE EVALUATION THAT WAS PERFORMED ON THE RETURNED UNIT. IT WAS NOT NECESSARY TO ACHIEVE REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE, AS THE DEFECT WAS VISUALLY SEEN. VISUAL/MICROSCOPIC EXAMINATION: 7080821: THE PACKAGE WAS PARTIALLY OPENED AT THE BOTTOM END OF THE BLISTER PACK. 7026572: THE PACKAGE WAS PARTIALLY OPENED AT THE TOP END OF THE BLISTER PACK 7048945: PACKAGE ONE WAS PARTIALLY OPENED AT TOP OF THE BLISTER PACK, PACKAGE TWO HAD A COMPLETE SEAL. DEVICE HISTORY RECORD REVIEWS WERE PERFORMED ON ALL LOTS ASSOCIATED WITH THIS COMPLAINT. 7080821 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 9 FROM MARCH 28, 2017 THRU MARCH 30, 2017. 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. 7026572 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 8 FROM FEBRUARY 1, 2017 THRU FEBRUARY 2, 2017. 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. 7048945 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 11 FROM FEBRUARY 26, 2017 THRU MARCH 1, 2017. 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. THE ANALYSIS OF TOP WEB ADHESIVE 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. EVEN THOUGH THE PACKAGES CAME PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH ARE: SEAL TRANSFER AND TOP WEB GLUE, MEASURED WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. THE PACKAGING OPERATORS ARE RESPONSIBLE TO VERIFY THE SEAL TRANSFER/WIDTH AND THAT PACKAGES ARE ¿WATER LEAK TESTED¿ EVERY HOUR. THESE ATTRIBUTE INSPECTIONS ARE DONE TO VERIFY THAT THE PACKAGES ARE SEALED ADEQUATELY PRIOR TO PLACING THEM WITHIN THE DISPENSER. THIS IS ISSUE IS CURRENTLY BEING INVESTIGATED BY CAPA (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGES OF THE 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WERE NOT SEALED PROPERLY CAUSING POSSIBLE STERILITY ISSUES. THIS WAS OBSERVED PRIOR TO USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743602 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other