BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 3190025 · Received June 26, 2013

    Report

    Report Number
    9681834-2013-00080
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DXC
    PMA / PMN Number
    K070423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IN (B)(4) FOR FURTHER EVALUATION. INSPECTION AND TESTING OF THE RETURNED SAMPLE CONFIRMED THAT THE LARGE AND SMALL BALLOONS HAD BEEN STRETCHED AND THEN TORN ALONG THE CIRCUMFERENCE OF THE TWO BALLOONS. EVALUATION OF NON-DAMAGED AREAS OF THE RETURNED SAMPLE AND OF A RETAINED SAMPLE CONFIRMED THAT THERE WERE NO OTHER ANOMALIES OR DEFECTS. TESTING OF THE RETAINED SAMPLE CONFIRMED THAT THE DEVICE WAS ABLE TO BE OPENED WITHOUT DAMAGING THE BALLOONS, AND THAT AN EXCESSIVE FORCE HAD TO BE APPLIED IN ORDER TO CAUSE DAMAGE TO THE BALLOONS. WHILE THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, THE USER FACILITY DESCRIPTION OF THE EVENT IS MOST CONSISTENT WITH DAMAGE DUE TO THE USER APPLYING AN EXCESSIVE PULLING FORCE WHEN OPENING THE BAND PRIOR TO USE, RESULTING IN THE BALLOON BEING TORN. THE LABELING DOES ADDRESS THE POTENTIAL FOR AN EVENT RELATED TO DAMAGE OF THE TR BAND BALLOON IN THE INSTRUCTIONS-FOR-USE WITH THE FOLLOWING STATEMENT: "WHILE USING, BE CAREFUL NOT TO PUT EXCESSIVE LOAD ON THE PRESSURE CONFIRMATION BALLOON OR COMPRESSION BALLOON THAT COULD BREAK IT." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE TR BAND WAS NOTED TO BECOME DAMAGED AS IT WAS BEING PREPARED FOR USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: DURING PREPARATION FOR USE, THE VELCRO CLOSURE WAS NOTED TO HAVE BECOME STUCK TO THE BALLOON; UPON INSPECTION OF THE TR BAND A HOLE WAS FOUND IN THE BALLOON; THE INVOLVED TR BAND WAS NOT APPLIED TO THE PATIENT; AND ANOTHER TR BAND WAS USED WITH NO REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290454 TR BAND VASCULAR CLAMP DXC TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1