BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE CONNECTOR

    MDR report key: 1913023 · Received November 18, 2010

    Report

    Report Number
    2025816-2010-00106
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE REPORTED PRODUCT PROBLEM WAS NOT REPLICATED ON THE RETURNED (B)(4) CLAVE CONNECTOR AND MATING/ACCESS DEVICES. EXACT CAUSE OF THE EVENT IS UNK.

    Description of Event or Problem · 1

    INTL (B)(6) COMPLAINT REC'D. REPORTING LEAKAGE ISSUE WITH ONE (1) 011-C1000 CLAVE CONNECTOR. THE REPORT CITES A (B)(6) INCIDENT WHERE "INSULIN INFUSION NOT WORKING PROPERLY... PTS. LEVELS OF SUGAR WERE INCREASING. CLAVE WAS LEAKING AND INTERNAL PATHWAY BENT.". FOLLOW-UP INFO IDENTIFIED THAT THE PT REQUIRED. ANOTHER CENTRAL LINE TO BE INSERTED, INSULIN INFUSION WAS RESUMED, PT RETURNED TO BASELINE CONDITION. THE ACTUAL DEVICES INVOLVED IN THE INCIDENT WERE DISCARDED. ONE (1) SAME LOT PACKAGED 011-C1000, CLAVE CONNECTOR LOT# 1875875 WAS RETURNED FOR ANALYSIS ALONG WITH THE FOLLOWING MATING/ACCESS DEVICES: TWO (2) PACKAGED SENDAL PRESSURE SETS PA200-8C; ONE (1) PACKAGED B BRAUN IV STD LUER LOCK SET, (B)(4); ONE (1) PACKAGED BAXTER (B)(4) LUER LOCK INFUSION SET WITH VENTED DRIP CHAMBER, 15U FILTER, ONE (1) PACKAGED VYGON 220.100 EXT TUBING. VISUAL AND FUNCTIONAL TESTING AND EVALUATIONS WERE PERFORMED. THE (B)(4) CLAVE CONNECTOR WAS MATED TO EACH OF THE RETURNED DEVICE SETS. THE RESULTS RECORDED NO NON-CONFORMANCES, PERFORMANCE ISSUES. DIMENSIONAL EVALUATIONS WERE PERFORMED. THE FIVE RETURNED MATING DEVICES WERE DIMENSIONALLY CHECKED AND PASSED ISO STANDARDS (B)(4) FOR MALE LUER TAPERS. DIMENSIONAL EVAL OF THE RETURNED MATING DEVICE CONNECTORS' MALE LUER INNER (ID) DIAMETERS WERE ALSO PERFORMED. THE RESULTS RECORDED COMPATIBLE MEASUREMENTS (.062" TO .110") FOR ALL THE RETURNED MATING SETS EXCEPT THE TWO SENDAL PRESSURE SETS. THE SENDAL (B)(4) CONNECTORS' MALE LUER IDS MEASURED AT .112". THIS EXCEEDS THE ALLOWABLE DFU LABELED COMPATIBILITY RANGE FOR USE WITH THE ICU MEDICAL CLAVE. THE ENGINEERING ANALYSIS REPORT RECORDED NO FUNCTIONAL AND OR PERFORMANCE ISSUES WERE REPLICATED WITH THE RETURNED (B)(4) CLAVE CONNECTOR AND MATING SETS. THE ANALYSIS REPORT DID IDENTIFY A DIMENSIONAL COMPATIBILITY ISSUES WITH THE SENDAL (B)(4) CONNECTORS MALE LUER ID. PREVIOUS INVESTIGATIONS HAVE FOUND THAT USE OF A NON-ISO MALE LUER CONNECTOR, WHERE THE ID MALE LUER IS LARGER THAN 110" CAN COMPROMISE CLAVE ACTIVATION (PLUG) AND FLOW FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE CONNECTOR CLAVE CONNECTOR FPA ICU MEDICAL, INC. 011-C1000 1875875

    Patients

    Seq Age Sex Outcome Treatment
    1 VYGON 220.100 EXT. TUBING. SYRINGE(S) NOI| BAXTER (B)(4) LUER LOCK INFUSION SET| SENDAL PRESSURE SETS| BBRAUN IV STD. LUER LOCK SET