BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 3871121 · Received June 13, 2014

    Report

    Report Number
    9681834-2014-00160
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 13, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DXC
    PMA / PMN Number
    K070423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS RETURNED AND EVALUATED. TESTING OF THE RETURNED SAMPLE, INCLUDING A LEAK TEST AND MICROSCOPIC INSPECTION OF THE PORT COMPONENT, CONFIRMED THAT THERE WERE NO DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THERE WERE NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THE REPORTED ISSUE WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE WITH STATEMENTS SUCH AS "BE CAREFUL THAT NO FOREIGN PARTICLES GET INTO THE AIR INJECTION PORT WHEN INJECTING AIR. THE AIR COULD LEAK." ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN PLACED ON FILE BY QA AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE WAS AN AIR LEAK WHILE USING A TR BAND. THE USER FACILITY PROVIDED THE FOLLOWING INFORMATION: MINOR BLEEDING WAS DETECTED 20-30 MINUTES AFTER THE TR BAND WAS PLACED FOR HEMOSTASIS; THE DEVICE WAS CHANGED OUT FOR A NEW ONE; AND REPORTEDLY, THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351013 TR BAND VASCULAR CLAMP DXC TERUMO CORPORATION, ASHITAKA NA 140124

    Patients

    Seq Age Sex Outcome Treatment
    1