BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE IV BAD ACCESS DEVICE

    MDR report key: 4009068 · Received July 9, 2014

    Report

    Report Number
    2025816-2014-00078
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED OPERATION AND QUALITY ASSURANCE PERSONNEL REVIEWED AND ENGINEERING RESULTS, PARTICIPATED IN THE INVESTIGATION, DEVELOPED AND AS APPLICABLE PERFORMED/IMPLEMENTED THE CORRECTIVE ACTIONS ASSOCIATED WITH THIS INCIDENT. COMPREHENSIVE, DETAILED TRAINING AND RETRAINING SESSIONS WERE CONDUCTED WITH ALL INVOLVED ASSEMBLY ADN INSPECTION TEAMS TO EMPHASIZE THE IMPORTANCE OF THOROUGHLY FOLLOWING PROCEDURAL INSTRUCTIONS. AS INTERIM MEASURE HEIGHTENED INSPECTIONS HAVE BEEN INITIATED. A REVIEW OF THE MFG LOT BUILD RECORDS FOR THE REPORTED LOT #2811179 WAS PERFORMED. THE RESULTS RECORDED LOT #2811179 (MFG. DATE: 01/2014) (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LOT # RECORDED NO ADDITIONAL REPORTS. (B)(4). FINDINGS: ENGINEERING ANALYSIS FO THE ONE "AS-RECEIVED" (B)(4) CONFIRMED THE REPORTED PRODUCT ISSUE. THE INVESTIGATION AND ANALYSIS OF THIS ISSUE DETERMINED THE ROOT CAUSE WAS ATTRIBUTABLE TO MFG/INSUFFICIENT BOND DUE TO OPERATOR ERROR/OVERSIGHT. THE MANUFACTURER WILL CONTINUE TO CLOSELY MONITOR AND TREND FOR THIS ISSUE. THE COMPLAINT INVESTIGATION REPORT, RELEVANT PHOTOGRAPHS WERE PROVIDED TO THE REPORTING DISTRIBUTOR/FACILITY FOR THEIR REVIEW, UNDERSTANDING AND RECORDS.

    Description of Event or Problem · 1

    INTERNATIONAL (B)(6) COMPLAINT RECEIVED REPORTING A (B)(6) INCIDENT WHERE THE (B)(4) DEVICE "CLAVE SEPARATED FROM THE SPIKE. ENDOXAN LEAKED...NURSE WAS SPLASHED WITH ENDOXAN...THE NURSE WENT TO THE DEPARTMENT OF DERMATOLOGY AND PUT ON STEROID.". IT WAS ALSO REPORTED THAT IN (B)(6) CLINICIANS "DO NO WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE) AS THE BELIEF IS PPE GIVES PATIENT A FEELING OF FEAR." THE CLINICIAN WAS TREATED PER HOSPITAL PROTOCOLS AND DID NOT SUSTAIN ANY SERIOUS INJURIES OR ADVERSE OUTCOMES. DEVICE RETURN: ONE (1) USED (B)(4) DEVICE MATED ATTACHED TO A 5" ADD-ON SET. VISUAL INSPECTION AND ANALYSIS (PRE AND POST DECONTAMINATION) WAS PERFORMED. THE RESULTS RECORDED THE RETURNED (B)(4) CLAVE WAS SEPARATED FROM THE SPIKE, THUS CONFIRMING THE REPORTED PRODUCT ISSUE. ADDITIONAL MICROSCOPIC EXAMINATION OF THE AFFECTED COMPONENTS WAS ALSO PERFORMED. THE ENGINEERING ANALYSIS REPORT IDENTIFIED THERE APPEARED TO BE AN INADEQUATE BOND DUE TO THE LACK OF SOLVENT ON THE BONDED LUER SURFACES OF THE CALVE AND SPIKE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401304 CLAVE IV BAD ACCESS DEVICE CLAVE IV BAD ACCESS DEVICE FPA ICU MEDICAL, INC. 081-CH-10 2811179

    Patients

    Seq Age Sex Outcome Treatment
    1 BD SYRINGE