BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FED

    MDR report key: 5511907 · Received March 18, 2016

    Report

    Report Number
    2027111-2016-00239
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Report Date
    December 30, 2016
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FED
    PMA / PMN Number
    K993650
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FULL UDI UNKNOWN SINCE NO LOT NUMBER WAS PROVIDED. NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED FOR EVALUATION. LIMITED INFORMATION WAS PROVIDED REGARDING THE CUSTOMER'S EXPERIENCE. IN THE ABSENCE OF THE SUBJECT DEVICE AND FURTHER INFORMATION ABOUT THE EVENT, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE POTENTIAL LOTS INDICATES THAT THEY PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. DURING THE MANUFACTURING PROCESS, ALL FORTE URETERAL ACCESS SHEATH DEVICES ARE THOROUGHLY INSPECTED AND TESTED FOR FUNCTIONALITY AND PERFORMANCE PRIOR TO PACKAGING. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED UNKNOWN. "POSSIBLE MODELS: B7016 (BATCH NO. 1229932 OR 1226392), B7266 (BATCH NO. 1218596), B7076 (1220913), B7216 (BATCH NO. 1224790) OR B7276 (BATCH NO. 7276). NURSE ADVISED OF 2 UROLOGY CASES ABOUT 6 MONTHS AGO THAT CONVERTED TO PYELOPLASTY SURGERY, SHE COMMENTED THAT SHE FELT THE TIP OF OUR ACCESS SHEATH IS TOO SHARP, SHE ALSO MENTIONED SHE HAS BEEN TOO BUSY TO ADVISE APPLIED MEDICAL." TYPE OF INTERVENTION- PYELOPLASTY SURGERY. PATIENT STATUS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL TEAM MEMBER, FEBRUARY 22, 2016: "UNFORTUNATELY, THERE IS NO FURTHER INFORMATION OTHER THAN WHAT IS ON THE FORMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165788 FED FED APPLIED MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R