BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" SMALLBORE EXT. SET W/REMV. MICROCLAVE

    MDR report key: 3151879 · Received May 20, 2013

    Report

    Report Number
    2025816-2013-00051
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURERS PERFORMED A THOROUGH REVIEW OF THE REPORTED MFG LOT #2600778 PRODUCTION AND INSPECTION BUILD RECORDS. MFR INVESTIGATION: A REVIEW OF THE MFG LOT DATABASE FOR THE REPORTED LOT #2600778 (MFG DATE 11/2012) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED. THE LOT REVIEW SHOWED VISUAL, DIMENSIONAL, AND FUNCTIONAL QC LOT TESTING MET ALL SPECIFICATIONS. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE BUILD. CONCLUSION: THE INVOLVED BB33038 DEVICE WAS NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE(S) OF THE EVENT ARE UNK. THIS REPORT AND ASSOCIATED INFO HAVE BEEN ENTERED IN THE MANUFACTURER'S COMPLAINT DATABASE FOR MONITORING AND TRENDING.

    Description of Event or Problem · 1

    (B)(4) REPORT RECEIVED CONCERNING COMPONENT BREAKAGES WITH USE OF ONE B33038 7" SMALLBORE INFUSION EXT SET. IT WAS REPORTED THAT "...BEFORE SEDATION BEGAN, DOCTOR SLID THE CLASP TO OPEN IT. IT BROKE OFF AT THE CONNECTION OF THE TUBING ...UNABLE TO USE IV; HAD TO REPLACE THE EXTENSION TUBING AT THE HUB OF THE CATHETER. NO INJURY TO THE PT." ADDITIONAL USAGE INFO REQUESTED BUT NOT RECEIVED. THE B33038 DEVICE SET WAS DISCARDED/NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AND CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221517 7" SMALLBORE EXT. SET W/REMV. MICROCLAVE EXTENSION SET FPA ICU MEDICAL, INC. B33038 2600778

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR