BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7 "EXT. SET W/ REMV. MICROCLAVE

    MDR report key: 4203906 · Received July 23, 2014

    Report

    Report Number
    2025816-2014-00089
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: FOUR PACKAGED (UNUSED) 12515-01 DEVICE SETS, MULTIPLE LOT# WERE RETURNED. ENGINEERING TESTING AND ANALYSIS TO THE APPLICABLE PRODUCT SPECIFICATIONS WAS PERFORMED. THE RESULTS RECORDED NO ATTACHMENT, LEAKAGES AND OR FUNCTIONAL PERFORMANCE ISSUES WERE REPLICATED. ADDITIONAL ANALYSIS USING IN-HOUSE MATING DEVICE SAMPLE (22G IV CATHETER) WAS PERFORMED. THE RETURNED 12515-01 DEVICE MALE LUER SPIN COLLARS COMPONENTS WERE MATED TO THE IN-HOUSE SAMPLE FEMALE LUERS PER TYPICAL USAGE TIGHTENING CONDITIONS (1.0 IN LBS. OF TORQUE) THE SPIN COLLAR RETENTION FORCES WERE THAN MEASURED ON THE TORQUE METER AND THE VALUES RECORDED. THE CONNECTIONS MET THE SPECIFICATIONS. THIS SET-UP WAS THAN REPEATED AND THE DEVICES LEAK TESTED. THE RESULTS RECORDED NO ATTACHMENT ISSUES, CONNECTION ANOMALIES AND NO LEAKAGES WERE REPLICATED. WHILE NOT ALWAYS REPEATABLE, PREVIOUS ENGINEERING STUDIES WERE ABLE TO REPLICATE ATTACHMENT/MATING ANOMALIES WITH VARIOUS MATING DEVICES AND DEVICE SETS WITH SPIN COLLAR CONFIGURATIONS. THE ENGINEERING DATES IDENTIFIED VARIATIONS WITH VARIOUS IV CATHETER LUER COMPONENTS. FURTHER ENGINEERING EFFORTS IDENTIFIED MINOR ENHANCEMENTS TO OVERALL SPIN COLLAR FITMENTS THAT HAVE BEEN QUALIFIED AND ARE IN VARIOUS STAGES OF IMPLEMENTATION. THESE IMPROVEMENTS HAVE BEEN SHOWN TO ADDRESS MATING DEVICE COMPONENT VARIATIONS TO ENSURE DEEPER FITMENT/INITIAL RETENTIONS WITH SPIN COLLAR LUERS. FINDINGS: ENGINEERING TESTING AND ANALYSIS PER THE APPLICABLE PRODUCT SPECIFICATIONS OF THE RETURNED DEVICES RECORDED NO ATTACHMENT, LEAKAGES ISSUES AND OR OUT OF SPEC CONDITIONS. THIS REPORT AND THE ASSOCIATED INFORMATION HAVE BEEN PROVIDED TO THE REPORTING FACILITY FOR THEIR REVIEW AND RECORDS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING ATTACHMENT/LEAKAGE ISSUES WITH USE OF 12515-01 7" EXT. SETS W/REMV MICROCLAVE CLEAR CONNECTORS AND UNKNOWN TUBING SETS. IT WAS REPORTED" THE SET NOT CONNECTING TO THE IV TIGHTLY CAUSING IT TO COME APART AND BLOOD SPURTS EVERYWHERE." FOLLOW UP INFORMATION REPORTS THIS IS OCCURRING DURING HIGH PRESSURE/CONTRAST INJECTIONS. IT IS THE MFGERS. UNDERSTANDING THAT THERE WERE NO PATIENT INJURIES, ADVERSE CONSEQUENCES AND OR OUTCOMES. FOLLOW UP INFORMATION CONCERNING SET-UPS; MATING DEVICES, PROCEDURES ALTHOUGH REQUESTED HAVE NOT BEEN RESPONDED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432523 7 "EXT. SET W/ REMV. MICROCLAVE EXTENSION SET W/MICROCLAVE CONNECTOR FPA ICU MEDICAL, INC. 12515-01 33-710-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 NI UNK MATING TUBING LINE EXT. SETS