BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET

    MDR report key: 4479741 · Received January 20, 2015

    Report

    Report Number
    2025816-2015-00002
    Event Type
    Malfunction
    Date Received
    January 20, 2015
    Date of Event
    December 1, 2014
    Report Date
    January 9, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF THE MFG. LOT DATABASE FOR LOT#: 2914399 (MFG. DATE 08/2014) SHOWED 250 UNITS WERE MFG., TESTED, INSPECTED, AND RELEASED. VISUAL EXAMINATION: 17 UNUSED/OPENED ADMIN. SET (B9840) AND TWO UNUSED BD 24G INSYTE AUTOGUARD ANGIOCATH CATHETERS SHOWED NO ANOMALIES PRESENT. FUNCTIONAL TESTING SHOWED THAT THE SPIN COLLAR RETENTION VALUES WERE ALL WITHIN SPECIFICATION LIMITS. ALL MALE LUERS OF THE ADMIN. SETS (B9840) AND THE TWO FEMALE LUER OF THE 24G INSYTE AUTOGUARD ANGIOCATH CATHETERS MET THE ISO STANDARD 594-1 REQUIREMENTS. CONCLUSIONS: THE RETURNED DEVICES DID NOT MEET THE VISUAL, DIMENSIONAL AND FUNCTIONAL REQUIREMENTS OF THE PRODUCT PERFORMANCE SPECIFICATION. THERE WERE NO LEAKAGES OR LOOSE CONNECTIONS FOUND DURING THE EVALUATION. ICU WAS ABLE TO IDENTIFY TECHNIQUE RELATED VARIABLE THAT COULD BE CONTRIBUTING TO USER ISSUES. GUIDANCE FROM THAT EFFORT HAS BEEN COMMUNICATED TO THE CUSTOMER. IN ADDITION, POTENTIAL ENHANCEMENTS TO THE RELEVANT ICU MEDICAL PRODUCTS AND PROCESSES WERE IDENTIFIED. CONTINUOUS IMPROVEMENT TEAMS WERE FORMED TO REVIEW APPLICABLE DESIGN, MATERIALS, AND MANUFACTURING AND EQUIPMENT PROCESSING PARAMETERS. THOSE ENHANCEMENTS ARE IN VARIOUS STAGES OF QUALIFICATIONS AND COMPLETION.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING LIST#: B9840, 80" ADMIN SET W/ BRAVO 24, 0.2 MICRON FILTER, LOT: 2914399 (MFG DATE 08/2014). THE REPORT STATES, B9840 IS BECOMING DISCONNECTED OR IN TIME IS LOOSENING ENOUGH TO CREATE A LEAK FROM THE END OF THE TUBING WHERE IT CONNECTS TO THE BD INSYTE AUTOGUARD ANGIOCATH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47832 ADMINISTRATION SET 80" ADMIN SET W/ BRAVO 24M, 80FMG FMG ICU MEDICAL, INC. B9840 2914399

    Patients

    Seq Age Sex Outcome Treatment
    1 NI TWO BD 24G INSYTE AUTOGARD ANGIOCATH CATHETERS,