BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7878732 · Received September 14, 2018

    Report

    Report Number
    1710034-2018-00636
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Date of Event
    August 24, 2018
    Report Date
    November 19, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825449
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW WAS PERFORMED ON LOT NUMBER 6173926; THE LOT NUMBER WAS BUILT ON AFA LINE 9 FROM JUNE 23, 2016 THRU JUNE 25, 2016. PACKAGED ON PACKAGING LINE 11 FROM JUNE 26, 2016 THRU JUNE 27, 2016. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. RECEIVED ONE IAG BC 18GA UNIT FROM LOT NUMBER 6173926. PACKAGE WAS PARTIALLY OPENED, BUT THIS IS THE BASIS OF THE COMPLAINT. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL WIDTH WITH ADHESIVE TRANSFER FROM THE TOP WEB PAPER TO THE BOTTOM WEB FILM. THIS CHARACTERISTIC WAS MET. THE KEY VARIABLES THAT AFFECT THE PACKAGING SEAL ARE SEAL TRANSFER/WIDTH AND TOP WEB ADHESIVE PRESENCE. BOTH OF THESE VARIABLES WERE INCLUDED IN THE INVESTIGATION. THE DEFECT STATED IN THE DESCRIPTION OF THE COMPLAINT WAS CONFIRMED WITH THE RETURNED UNIT THAT WAS PARTIALLY OPEN AT BOTH ENDS. EVEN THOUGH THE PACKAGES WERE RECEIVED PARTIALLY OPENED, ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL WERE OBSERVED TO BE WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. BD SUPPLIER OLIVER-TOLAS (OT) 29LP USES A STANDARD REINFORCED PAPER THAT IS COMMON TO MANY OTHER SUPPLIERS, BUT THE ADHESIVE TYPE AND APPLICATION IS SPECIFIC TO OLIVER-TOLAS. THERE IS SUFFICIENT EVIDENCE TO DEMONSTRATE THE OT MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. (B)(4) WAS OPENED TO INVESTIGATE THE PACKAGE SEAL INTEGRITY COMPLAINTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER HAD STERILE BREACH DUE TO PACKAGING ADHESIVE FAILURE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD STERILE BREACH DUE TO PACKAGING ADHESIVE FAILURE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720218 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6173926 30382903825449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other