BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROCLAVE CLEAR CONNECTOR

    MDR report key: 3151876 · Received May 20, 2013

    Report

    Report Number
    2025816-2013-00031
    Event Type
    Other
    Date Received
    May 20, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION: DEVICE RETURN: ONE (1) USED 1252-01, MICROCLAVE CLEAR CONNECTOR. NO MATING DEVICES WERE RETURNED TO EVALUATE. VISUAL ANALYSIS OF THE RETURNED 12512-01 DEVICE RECORDED COMPONENT DAMAGES/SLIT PROPAGATION TO THE EDGE OF THE SILICONE PLUG. FUNCTIONAL PERFORMANCE TESTS WERE CONDUCTED. THE RESULTS RECORDED EVIDENCE OF INTERNAL LEAKAGE AND EXTERNAL LEAKAGE BETWEEN THE CAP AND SPIKE THREADS. ENGINEERING ASSESSMENT: THE LEAKAGE OCCURRED AS A RESULT OF THE 12512-01 COMPONENT DAMAGES INCLUDING SLIT TEARS THAT PROPAGATED TO THE EDGE OF THE SILICONE PLUG. THIS TYPE OF DAMAGE IS TYPICAL OF EXTENDED ACCESS WITH A MATING DEVICE THAT HAS A MALE LUER WITH AN INSIDE DIAMETER GREATER THAN 0.110". MANUFACTURING LOT RECORD REVIEW. A REVIEW OF THE MANUFACTURING LOT DATABASE FOR THE REPORTED LOT NUMBER 20-688-HE (MFG DATE 08/01/2012) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MANUFACTURING BUILD. CONCLUSION: VISUAL EVAL OF THE "AS-RECEIVED" USED 12512-01 CONFIRMED COMPONENT DAMAGES, TESTING CONFIRMED INTERNAL AND EXTERNAL LEAKAGES DUE TO THE DAMAGED COMPONENTRY. THE CAUSE OF THE LEAKAGE IS ATTRIBUTABLE TO INCORRECT USAGE/INCOMPATIBLE MATING AND OR ACCESS DEVICES. PER THE DFU, THE MICROCLAVE CONNECTOR SHOULD ONLY BE ACCESSED WITH (B)(4) COMPLIANT MALE LUERS WITH A MALE LUER INSIDE DIAMETER BETWEEN 0.062" AND 0.110" THIS COMPLAINT REPORT AND INVESTIGATION FINDINGS HAVE BEEN ENTERED IN THE MANUFACTURER'S COMPLAINT DATABASE FOR MONITORING AND TRENDING. ADDITIONALLY, THE INVESTIGATION FINDINGS HAVE BEEN COMMUNICATED TO THE FACILITY FOR THEIR REVIEW AND UNDERSTANDING.

    Description of Event or Problem · 1

    (B)(4) REPORT RECEIVED CONCERNING PRODUCT ISSUES (CRACKS/LEAKAGES) WITH USE OF TWO 12512-01 MICROCLAVE CLEAR CONNECTORS. THE REPORT STATES "...(B)(6) FOUND TO HAVE TPN LEAKING FROM CRACK IN CLAVE. THERE WERE TWO SUCH DEVICES FOUND TO BE LEAKING ON DIFFERENT INFANTS. THE DEVICES CAME FROM THE SAME LOT AND THAT LOT HAS BEEN PULLED." THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED AS A RESULT OF THESE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221550 MICROCLAVE CLEAR CONNECTOR CONNECTOR FPA ICU MEDICAL, INC. 12512-01 20-688-HE

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR SYRINGE: MANUFACTURER, MAKE AND MODEL UNK