BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL GUIDING SHEATH

    MDR report key: 3770029 · Received April 24, 2014

    Report

    Report Number
    1118880-2014-00010
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 24, 2014
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT #2 IS BEING SUBMITTED TO PROVIDE THE DATE THE MANUFACTURING FACILITY RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT AND/OR EVALUATION OF THE ACTUAL SAMPLE. THIS DATE WAS INADVERTENTLY OMITTED IN THE PREVIOUS FOLLOW-UP REPORT.THE INFORMATION PROVIDED BELOW LISTS THE DATE(S) THE ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURING FACILITY:FOLLOW-UP #1 = 5/20/2014.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT 1118880-2014-00010 TO PROVIDE UPDATED INFORMATION BASED ON THE EVALUATION OF THE DEVICE SAMPLE RECENTLY RETURNED FROM THE USER FACILITY. THE INITIAL REPORTED MALFUNCTION OF THE VALVE LEAKAGE WAS DETERMINED NOT TO BE CORRECT. IN ADDITION, UPON EVALUATION OF THE DEVICE IT WAS DETERMINED THAT THERE WERE NO DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATION WERE MET. THEREFORE, THIS REPORT DOES NOT MEET THE CRITERIA FOR ADVERSE EVENT REPORTING. HOWEVER, BECAUSE THE INITIAL REPORT HAS ALREADY BEEN SUBMITTED PRIOR TO THE ADDITIONAL INFORMATION BEING RECEIVED, THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP TO FURTHER DETAIL THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THERE WAS REPORTEDLY NO IMPACT TO THE PATIENT & AN ESTIMATED VOLUME WAS NOT AVAILABLE, THE EVENT DESCRIPTION INDICATES THAT SOME MINOR BLOOD LOSS MAY HAVE OCCUR. RESULTS: IS BASED ON EVALUATION OF USER FACILITY INFORMATION; BASED ON RESERVE SAMPLE EVALUATION CONCLUSION: IS BASED ON RESERVE SAMPLE EVALUATION. THE RETURN SAMPLE FOR THIS REPORT WAS NOT AVAILABLE. THEREFORE, THE INVESTIGATION WAS CONDUCTED BASED ON A REVIEW OF INFORMATION PROVIDED BY THE USER FACILITY, RETAINED SAMPLES AND MANUFACTURING QUALITY RECORDS. INSPECTION AND TESTING OF RETAINED SAMPLES FROM THE REPORTED LOT AND SURROUNDING LOTS CONFIRMED THAT THERE WERE NO DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THERE WAS NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #2 FOR MFG. REPORT #1118880-2014-00010 TO PROVIDE THE DATE THAT ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A LEAKAGE ON THE VALVE OF THE SHEATH. FOLLOW-UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THAT: (1) PROCEDURE WAS COMPLETED SUCCESSFULLY; AND (2) THE PATIENT IS REPORTED IN STABLE CONDITION.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 1118880-2014-00010 TO PROVIDE THE RESULTS OF THE EVALUATION OF THE RETURNED SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250219 RENAL GUIDING SHEATH CATHETER INTRODUCER DYB TERUMO MEDICAL CORPORATION NA QH10

    Patients

    Seq Age Sex Outcome Treatment
    1