BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7014715 · Received November 9, 2017

    Report

    Report Number
    1710034-2017-00329
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    October 14, 2017
    Report Date
    October 27, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION: RECEIVED ONE UNUSED IAG 22GA UNIT IN A PARTIALLY OPENED PACKAGE FROM THE LOT NUMBER 6182878. THE PACKAGE WAS PARTIALLY OPENED AT THE BOTTOM OF THE BLISTER PACK. 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. A DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 6182878 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 8 FROM JULY 7, 2016 THRU JULY 11, 2016. PER REVIEW OF THE DHR¿S 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. 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. 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. EVEN THOUGH THE PACKAGE 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. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE THIS IS ISSUE IS CURRENTLY BEING INVESTIGATED BY CAPA (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING ON A 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS NOT SEALED. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795535 22 G X 1IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6182878 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other