BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7587809 · Received June 11, 2018

    Report

    Report Number
    1710034-2018-00347
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    May 29, 2018
    Report Date
    September 20, 2018
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED FIVE UNUSED IAG 22GA UNITS IN PARTIALLY OPENED PACKAGES AND THREE UNUSED REPRESENTATIVE IAG 22GA UNITS IN SEALED PACKAGES FROM THE LOT NUMBER 7110801. CUSTOMER IDENTIFIED THE REPORTED DEFECT OF OPEN SEALS AND DOCUMENTED THE SAME WITH PHOTOGRAPHS. FIVE OF THE PACKAGES WERE PARTIALLY OPENED AT BOTH END OF THE BLISTER PACK. THE SEALS WERE NOT COMPROMISED IN THE REPRESENTATIVE UNITS. 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 TOGETHER IS UV FLUORESCENT. THE ANALYSIS REVEALED AN ADEQUATE TRANSFER (ADHESIVE) FROM THE TOP WEB TO THE BOTTOM WEB. THE KEY VARIABLES THAT AFFECT THE SEAL ARE: SEAL TRANSFER/ WIDTH AND TOP WEB ADHESIVE PRESENCE. BOTH OF THESE VARIABLES WERE LOOKED AT DURING THE INVESTIGATION. THE DEFECT PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE WAS CONFIRMED WITH THE RETURNED UNITS. EVEN THOUGH THE PACKAGES WERE PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL WERE OBSERVED TO BE WITHIN SPECIFICATION. DHR REVIEW WAS PERFORMED ON THE LOT NUMBER 7110801: THE LOT NUMBER WAS MANUFACTURED ON AFA LINE 5 FROM APRIL 25, 2017 THRU APRIL 30, 2017. PACKAGED ON PACKAGING LINE 11 FROM APRIL 30, 2017 THRU MAY 2, 2017. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH. IT WAS STATED ¿HE PACKAGES WEREN'T SEALED PROPERLY.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    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.

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH. IT WAS STATED ¿HE PACKAGES WEREN'T SEALED PROPERLY.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH. IT WAS STATED ¿HE PACKAGES WEREN'T SEALED PROPERLY.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432088 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7110801 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other