BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" MICROCLAVE PRESSURE INFUSION EXT. SET

    MDR report key: 4302833 · Received November 4, 2014

    Report

    Report Number
    2025816-2014-00134
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    July 1, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FUNCTIONAL AND PERFORMANCE TESTING OF THE 12514-01 DEVICE SETS TO THE APPLICABLE PRODUCT SPECIFICATIONS RECORDED NO ATTACHMENT ANOMALIES, LEAKAGES AND OR PERFORMANCE ISSUES AND OR OUT OF SPEC CONDITIONS. ADDITIONAL ENGINEERING ASSESSMENTS WERE PERFORMED WHERE THE 12514-01 DEVICES SETS MALE LUER/SPIN COLLARS WERE ATTACHED TO THE FEMALE LUER OF THE JELCO CATHETER USING 1.0 IN LBS OF TORQUE, SIMULATING NORMAL TIGHTENING CONDITIONS. THE SPIN COLLAR RETENTION (AMOUNT OF FORCE FOR IT TO LOOSEN) FROM THE FEMALE LUER OF THE CATHETER WAS MEASURED. THE RESULTS RECORDED VALUES THAT MET/EXCEEDED MINIMUM RANGE. THE 12514-01 DEVICE SET WAS THAN MATED/ATTACHED TO THE RETURNED JELCO CATHETER AND LEAK TESTED AT 45 PSIG. THE RESULTS RECORDED NO ATTACHMENT ISSUES AND OR LEAKAGES WERE REPLICATED. A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 32-567-HE (MFG. DATE 08/2013) SHOWS (B)(4) UNITS WERE MFGD., TESTED, INSPECTED, AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG LOT BUILD. FINDINGS: ENGINEERING TESTING AND ANALYSIS OF THE RETURNED 12514-01 DEVICE SET RECORDED NO ATTACHMENT ISSUES, LEAKAGES AND OR OUT OF SPEC CONDITIONS. THE EXACT CAUSE OF THE REPORTED EVENTS/PRODUCT ISSUES ARE UNK.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED CONCERNING ATTACHMENT/LEAKAGE ISSUES WITH USE OF 12514-01, 7" MICROCLAVE PRESSURE INFUSION SETS. IT WAS REPORTED THAT THE SETS "LUER LOCK...SET IS NOT CONNECTING TO IV CORRECTLY. OFTEN TIMES IT WILL NOT TWIST AT ALL, OR WILL CONNECT/TWIST ON ONLY HALF WAY AND STOP OR IT WILL DISCONNECT ON IT'S OWN...ALSO HAVE ISSUES WITH BLOOD LEAKING FROM SWABABLE END." THERE WERE NO REPORTED ADVERSE PT. CONSEQUENCES AND OR OUTCOMES. THE MFGER. REQUESTED ADDITIONAL EVENT/DEVICE USAGE DETAILED INFO. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSES. DEVICE RETURN: ONE USED 12514-01 DEVICE SET; ONE JELCO PROTECT IV CATHETER. MFGERS. INVESTIGATION: VISUAL INSPECTION RECORDED NO OBVIOUS ABNORMALITIES WITH THE RETURNED DEVICE SAMPLES. DIMENSIONAL ASSESSMENTS OF THE JELCO PROTECT IV CATHETERS LUER CONNECTOR RECORDED THE COMPONENTS MEET THE ISO STANDARD 594-1 FOR LUER TAPERS. THERE WERE NO DIMENSIONAL COMPATIBILITY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708330 7" MICROCLAVE PRESSURE INFUSION EXT. SET IV EXTENSION SET FPA ICU MEDICAL, INC. 12514-01 32-567-HE

    Patients

    Seq Age Sex Outcome Treatment
    1 NI JELCO PROTECT IV CATHETER| SYRINGES NOI