BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE CATHETER

    MDR report key: 4425890 · Received December 18, 2014

    Report

    Report Number
    3005471919-2014-00002
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    November 17, 2014
    Report Date
    December 18, 2014
    Manufacturer
    CURE MEDICAL LLC.
    Product Code
    EZD
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT CATHETER AND BOX WERE RETURNED FOR EVAL, BUT THE CATHETER PACKAGING WAS NOT. UPON INSPECTION, THE CATHETER SHOWED A V-SHAPED CUT NEAR THE EYELETS WHICH IS NOT INDICATIVE OF ANY OF THE MFG PROCESSES FOR THIS CATHETER. INSPECTION OF THE CARTON DID NOT SHOW ANY EVIDENCE OF AN EXTERNAL CUT PENETRATING THE CARTON. THE ROOT CAUSE COULD NOT BE DETERMINED, AND THIS APPEARS TO BE A UNIQUE EVENT. ALL CATHETERS UNDERGO 100% VISUAL INSPECTION DURING THE MFG PROCESS. THE MFR HAS BEEN NOTIFIED AND HAS MADE THE INSPECTORS AWARE OF THIS EVENT AND DEFECT. MFR HAS REVIEWED DEVICE HISTORY RECORDS, QUALITY INSPECTION DATA AND COMPLAINT HISTORY FOR THE DEVICE. MFR HAS REPORTED THE MALFUNCTION TO PERSONNEL AT MFG FACILITY FOR ADD'L INVESTIGATION. REVIEW OF FINAL INSPECTION REPORT AND DHR FOR THIS LOT INDICATES NO SIMILAR DEFECTS OBSERVED. A REVIEW OF THE COMPLAINT HISTORY FILE AND INCOMING INSPECTION RECORDS FOR THIS PRODUCT FAMILY INDICATES NO RELATED COMPLAINTS OR RELATED DEFECTS OBSERVED. AN UNRELATED NON-CONFORMITY REPORT WAS MADE ON THIS LOT. ALTHOUGH THE ROOT CAUSE OF THE INCIDENT EXPERIENCE COULD NOT BE DETERMINED, CURE MEDICAL WILL CONTINUE TO MONITOR THE PROCESS AND TAKE APPROPRIATE ACTION AS NECESSARY. THIS DOCUMENT REPRESENTS OUR INITIAL/FINAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED BLEEDING AND DISCOMFORT AFTER WITHDRAWING CATHETER. PT REPORTED THAT CATHETER STOPPED AFTER BEING WITHDRAWN TWO INCHES AND HE HAD TO PULL HARD TO RELEASE CATHETER. PT EXPERIENCED DISCOMFORT AND OBSERVED SOME BLOOD IN URINE (HEMATURIA) AFTER CATHETERIZATION. PT HAS HAD SUCCESSFUL CATHETERIZATION SINCE EVENT. RETURNED CATHETER SHOWED A V-SHAPED CUT NEAR THE EYELETS. PT REPORTED NO BREACH/CUT IN CATHETER PACKAGING. PT WAS PRESCRIBED ANTIBIOTIC AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835468 CURE CATHETER UROLOGICAL CATHETER EZD CURE MEDICAL LLC. M14 140730-2

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other