BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND RADIAL COMPRESSION DEVICE

    MDR report key: 17170410 · Received June 21, 2023

    Report

    Report Number
    1118880-2023-00281
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 15, 2023
    Report Date
    June 21, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DXC
    PMA / PMN Number
    K213531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED A3: PATIENT SEX: REQUESTED, NOT PROVIDED A4: WEIGHT: REQUESTED, NOT PROVIDED A5: ETHNICITY: REQUESTED, NOT PROVIDED A6: RACE: REQUESTED, NOT PROVIDED D4: LOT NUMBER: REQUESTED, UNKNOWN D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER D4: UDI: UNKNOWN DUE TO UNKNOWN LOT NUMBER D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED E3: OCCUPATION: LEAD TECH H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVEALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP # 1 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 FOR POSITIONING ISSUES OF THE TR BAND 2 BECAUSE THE SAMPLE WAS NOT RETURNED FOR ASSESSMENT. WITHOUT A SAMPLE, THE EXACT ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THE USER IS NOT APPLYING THE BAND CORRECTLY INITIALLY, LEADING TO SLIPPING ON THE WRIST. REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE TO THE UNKNOWN LOT NUMBER. CURRENTLY NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE HAZARD BASED RISK TABLE (HBRT).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE TR BAND 2 SLIPPED WHEN APPLIED AFTER REMOVING THE RADIAL SHEATH. THE CUSTOMER STATED THAT IF THE BAND SLIPS FROM ITS DESIRED LOCATION IT WILL LIKELY LEAD TO A LATE BLEED. THEY ALSO COMMENTED THAT THE PLASTIC MATERIAL ON THE TR BAND 2 IS SLIPPERY COMPARED TO THE TR BAND 1. THE CUSTOMER ALSO STATED THAT MOVING FORWARD THEY HAVE BEEN EXTRA CAREFUL TO BE SURE THE SKIN IS EXTRA DRY BEFORE APPLYING THE TR BAND 2. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: THEY DID NOT HAVE ANY ISSUES OR NEGATIVE PATIENT OUTCOME. THE TR BAND DID NOT LOSE AIR. THEY SUCCESSFULLY ACHIEVED HEMOSTASIS. THE CUSTOMER STATED THAT THE PLASTIC ON THE NEW TR BAND IS MUCH MORE SLIPPERY AND DIFFICULT TO PLACE IT CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215582 TR BAND RADIAL COMPRESSION DEVICE CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown RADIAL SHEATH