BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMLLBORE PRESSURE INFUSION EXT. SET

    MDR report key: 3650517 · Received January 15, 2014

    Report

    Report Number
    2025816-2013-00152
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    November 1, 2013
    Report Date
    December 13, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION: A REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER/ SIMILAR PROBLEM DID NOT RECORD ANY ADDITIONAL REPORTS/ INVESTIGATIONS IDENTIFYING A MFR OR DESIGN RELATED NON-CONFORMANCE. CONCLUSION: THE INVOLVED DEVICE(S) WERE NOT RETURNED FOR ANALYSIS AND INVESTIGATION. THE CAUSE OF THE REPORTED INCIDENT/ PRODUCT ISSUE IS UNK. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER/SIMILAR PROBLEM DID RECORD ADDITIONAL REPORTS/INVESTIGATIONS. A REVIEW OF THOSE INVESTIGATIONS WHERE DEVICES WERE RETURNED RECORDED MIXED RESULTS, INCLUDING NO DEFECT FOUND; USAGE; CANNOT DETERMINE. THE MFR'S COMPLAINT TEAM REVIEWED THE REPORTED INCIDENT/PRODUCT ISSUES. (B)(4) MGMT REVIEW OF IN-PROCESS ASSEMBLY/QUALITY TREND REPORTS IDENTIFIED NO ADVERSE TRENDS OR CONTRIBUTING ISSUES FOR THE APPLICABLE COMPONENTS/SUB ASSY BUILDS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED CONCERNING CONNECTION ISSUES WITH USE OF 12517-01, 7" SMALLBORE PRESSURE INFUSION EXT. SET W/REMV MICROCLAVE. FACILITY CLINICIANS REPORTED "IN THE PAST WEEK OR SO WE HAVE HAD ISSUES AGAIN WITH THE CLEAR CAP ON THE INT'S COMING OF FIN THE MIDST OF PROCEDURES, OR BEFORE PROCEDURE BEGINS. THE NURSES WHO HAVE INSERTED THEM ARE BEING DILIGENT ABOUT CHECKING THE CAPS WHEN INSERTING THE INT'S FALLING OFF THE TUBINGS AFTER SEVERAL USES. WE ALSO HAD AN INPATIENT DELIVERED TO US, AND WHEN THE NURSE PULLED BACK THE BLANKET TO CHECK THE INT, THE CAP WAS GONE COMPLETELY AND THE PT WAS IN A PUDDLE OF BLOOD." THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38671 SMLLBORE PRESSURE INFUSION EXT. SET SMLLBORE PRESSURE INFUSION EXT. SET FPA ICU MEDICAL, INC. 12517 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI UNK MATING/ACCESS DEVICES