BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 2981460 · Received February 27, 2013

    Report

    Report Number
    9681834-2013-00021
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DXC
    PMA / PMN Number
    K070423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IN JAPAN FOR EVALUATION. INITIAL MACROSCOPIC INSPECTION OF THE RETURNED SAMPLE REVEALED NO VISIBLE DEFECTS OR ANOMALIES. HOWEVER, FUNCTIONAL TESTING OF THE DEVICE CONFIRMED A LEAK AT THE AIR INJECTION PORT. MAGNIFIED INSPECTION REVEALED A 1-MM PIECE OF NYLON MATERIAL ON THE SEAL SURFACE OF THE BACK-FLOW VALVE. THE FRAGMENT APPEARS TO BE CONSISTENT WITH A DETACHED LOOP FROM THE WRIST-BAND'S HOOK & LOOP FASTENER. IT IS THEORIZED THAT THE FRAGMENT OF A LOOP BECAME DETACHED AS THE BAND WAS BEING PLACED AND THEN, RESULTED IN THE REPORTED AIR LEAK DUE TO INTERFERING WITH THE SEALING SURFACE OF THE BACK-FLOW VALVE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THERE HAVE BEEN NO REPORTS OF A SIMILAR FAILURE MODE FOR THIS LOT NUMBER. THEREFORE, THIS APPEARS TO HAVE BEEN AN ISOLATED EVENT. IN ADDITION, THE PRODUCT IS 100% TESTED FOR LEAKAGE PRIOR TO PACKAGING. THE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH A DEFLATION EVENT IN THE INSTRUCTIONS-FOR-USE WITH STATEMENTS SUCH AS: "BE CAREFUL THAT NO FOREIGN PARTICLES GET INTO THE AIR INJECTION PORT WHEN INJECTING THE AIR. THE AIR COULD LEAK"; AND "PATIENT SHOULD NOT BE LEFT UNATTENDED WHILE THE TR BAND IS IN USE." 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 THE TR BAND WOULD NOT HOLD PRESSURE DURING USE TO ASSIST WITH ACHIEVING HEMOSTASIS FOLLOWING A TRANS-RADIAL INTERVENTIONAL PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: IT WAS NOTED THAT THE BAND WAS NOT HOLDING AIR AFTER THE BAND WAS PLACED AND ATTEMPTED TO BE INFLATED; A SECOND TR BAND WAS PLACED AND INFLATED WITHOUT DIFFICULTY; AND FOLLOW-UP COMMUNICATION CONFIRMED THAT THE PATIENT WAS 'FINE.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85457 TR BAND VASCULAR CLAMP DXC TERUMO CORPORATION, ASHITAKA NA 120711

    Patients

    Seq Age Sex Outcome Treatment
    1