BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8290442 · Received January 30, 2019

    Report

    Report Number
    1710034-2019-00130
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 10, 2019
    Report Date
    March 7, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DURING DHR REVIEW ONE NON-RELATED QN WAS INITIATED DURING PRODUCTION WHERE DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED PER CONTROL PLAN. ALL OTHER CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. RECEIVED 1 IAG UNIT FROM LOT NUMBER: 7062991 ALL COMPONENTS WITHIN WERE PRESENT AND INTACT. THE UNIT RECEIVED WAS PARTIALLY OPEN AT BOTH ENDS 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. CONCLUSION(S): SUPPLIER ¿ DEFECTIVE MATERIAL BD SUPPLIER OLIVER-TOLAS 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 OLIVER-TOLAS MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLISTER PACKAGING OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FOUND OPENED DURING STORAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 THE BLISTER PACKAGING OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FOUND OPENED DURING STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83583 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7062991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other