BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 17010575 · Received May 26, 2023

    Report

    Report Number
    1118880-2023-00120
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    May 8, 2023
    Report Date
    May 26, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DXC
    UDI-DI
    00389701012469
    PMA / PMN Number
    K213531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO CORRECT SECTION G4 AS THE INCORRECT 510K NUMBER WAS INADVERTENTLY SUBMITTED AS K152525 AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF DEVICE HISTORY RECORD (DHR) SHOWED THERE WERE NO ISSUES NOTED DURING MANUFACTURE OF THE PRODUCT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. CURRENTLY NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE FAILURE MODE AND EFFECTS ANALYSIS (FMEA)/HAZARD BASED RISK TABLE (HBRT).

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: INVENTORY MANAGER. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE BLADDER WOULD NOT HOLD AIR IN THE BAND. THE PROCEDURE PERFORMED WAS A RADIAL HEART CATHETERIZATION. THERE WAS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 11 MAY 2023: IT WAS NO CLEAR HOW MUCH AIR WAS IN THE BAND. THE BAND WOULD NOT HOLD AIR AND THE STAFF NOTICED THIS AS THEY WERE TAKING THE BLADDER DOWN. THE DEVICE WAS NOT MANIPULATED IN ANY WAY. THE PRODUCT WAS STORED IN THE LAB IN A TEMPERATURE-CONTROLLED ENVIRONMENT. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. NO OTHER DEVICES WERE USED AT THE ACCESS SITE. THERE WAS VERY LITTLE BLOOD LOSS, LESS THAN 250CC'S. ADDITIONAL INFORMATION WAS RECEIVED ON 15 MAY 2023: THE TR BAND REMAINED ON THE PATIENT; IT WAS NOT SWITCHED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886125 TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION N/A 0000326994 00389701012469

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown