BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" EXT. SET W/REMV MICROCLAVE

    MDR report key: 4265099 · Received October 21, 2014

    Report

    Report Number
    2025816-2014-00118
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 25, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR REQUESTED ADDITIONAL EVENT/DEVICE USAGE DETAILED INFO. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSES. MFR'S INVESTIGATION: VISUAL INSPECTION RECORDED NO OBVIOUS ABNORMALITIES WITH THE RETURNED PACKAGED DEVICE SAMPLES. DIMENSIONAL ASSESSMENTS OF EACH OF THE THREE 12515-01 SETS MALE LUER SPIN COLLAR CONNECTORS AND THE BD INSYTE CATHETER FEMALE LUER CONNECTOR RECORDED THE COMPONENTS MEET THE ISO STANDARD 594-1 FOR LUER TAPERS. THERE WERE NO DIMENSIONAL COMPATIBILITY ISSUES. FUNCTIONAL AND PERFORMANCE TESTING OF THE THREE RETURNED 12515-01 DEVICE SETS TO THE APPLICABLE PRODUCT SPECS RECORDED NO ATTACHMENT ANOMALIES, LEAKAGES AND OR PERFORMANCE ISSUES AND OR OUT OF SPEC CONDITIONS. ADDITIONAL ENGINEERING ASSESSMENTS WERE PERFORMED WHERE THE 12515-01 DEVICES WETS MALE LUER/SPIN COLLARS WERE ATTACHED TO THE FEMALE LUER OF THE BD INSYTE 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 BD CATHETER WAS MEASURES. THE RESULTS RECORDED VALUES THAT MET/EXCEEDED MINIMUM RANGE. EACH OF THE 12515-01 DEVICE SETS WERE THAN MATED/ATTACHED TO THE RETURNED BD INSYTE CATHETER AND LEAK TESTED AT 45 PSIG. THE RESULTS RECORDED NO LEAKAGES WERE REPLICATED. A REVIEW OF THE MFG LOT BUILD DATABASE FOR THE REPORTED LOT# 35-989-SJ (MFG DATE 12/2013) SHOWS 27000 UNITS WERE MFG, TESTED, INSPECTED, AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG LOT BUILD. FINDINGS: ENGINEERING TESTING AND ANALYSIS OF THE THREE RETURNED 12515-01 DEVICE SET SAMPLES RECORDED NO LEAKAGES, PERFORMANCE AND OR OUT OF SPEC CONDITIONS. THE ACTUAL INVOLVED DEVICES WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE(S) OF THE REPORTED EVENTS/PRODUCT ISSUES ARE UNK.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED CONCERNING LEAKAGE ISSUES WITH USE OF 12515-01, 7 INCHES EXT SET W/REMV MICROCLAVE CONNECTOR, LOT# 35-989-SJ. FACILITY CLINICIANS REPORT "SETS WERE LEAKING AROUND THE CONNECTION WHERE THE EXTENSION SET IS ATTACHED TO THE BD AUTOGUARD ANGIOCATH." THERE WERE NO REPORTED PT INJURIES AND OR ADVERSE CONSEQUENCES. THE DEVICES WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669311 7" EXT. SET W/REMV MICROCLAVE IV EXTENSION SET FPA ICU MEDICAL, INC. 12515-01 35-989-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 NI BD INSYTE AUTOGUARD 18G CATHETER| SYRINGES NOI