BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER

    MDR report key: 10497907 · Received September 5, 2020

    Report

    Report Number
    3005483737-2020-00016
    Event Type
    Malfunction
    Date Received
    September 5, 2020
    Date of Event
    March 12, 2019
    Report Date
    September 5, 2020
    Manufacturer
    DEGANIA MEDICAL DEVICES PVT. LTD
    Product Code
    KOD
    PMA / PMN Number
    K860484
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "THE CUSTOMER REPORTED THAT "THE CATHETER HAS SLID OUT AND IN THE BALLOON IT HAS LIKE A PUNCTURE SITE." THERE WAS NO COMPLAINT SAMPLE AVAILABLE. WE REVIEWED THE BATCH HISTORY RECORDS OF LOT # S16000779 INCLUDING 100% VISUAL INSPECTION AND 100% INFLATION DEFLATION TEST OF THE BALLOONS AND DID NOT DETECT ANY NON-CONFORMITY DURING THE EVALUATION OF THE BATCH PRODUCTION RECORDS. THE RETAIN SAMPLES FROM THE SAME BATCH WAS TESTED AND IT FUNCTIONED PROPERLY, THE INFLATION AND DEFLATION TEST OF BALLOON DID NOT REVEAL ANY NON-CONFORMITY. SO, SINCE THE BATCH HISTORY REVIEW AND TESTING OF RETAIN SAMPLES SHOWED NO PUNCTURE AND NO BALLOON PROBLEM IN THE BATCH, AND THE ACTUAL SAMPLE WAS UNAVAILABLE FOR OUR EVALUATION, WE CONSIDER THIS COMPLAINT AS NOT JUSTIFIED. THIS MEDICAL DEVICE REPORT IS FILED RETROSPECTIVELY FOLLOWING FDA OBSERVATION NUMBER 4 RECEIVED BY DEGANIA MEDICAL DEVICES PVT. LTD. DURING THE FDA INSPECTION OF 4-7 OF NOVEMBER 2019. THE OBSERVATION WAS RELATED TO THE FACT THAT DEGANIA MEDICAL DEVICES PVT. LTD. DID NOT ESTABLISH PROCEDURES FOR REPORTING MDRS TO FDA AS A MANUFACTURER. TILL THEN ALL COMPLAINTS RELATED TO THE DEVICES PRODUCED BY DMD WERE ASSESSED FOR MDR REPORTABILITY AND SUBMITTED AS NECESSARY TO FDA BY DEGANIA SILICONE LTD. ANOTHER Q MEDICAL DEVICES DIVISION CLOSELY AFFILIATED WITH DMD. DMD CAPA NUMBER 73/19 WAS ISSUED TO ADDRESS THE OBSERVATION; ONE OF THE CAPA ACTION REQUIRES DMD TO PERFORM RETROSPECTIVE REVIEW OF ALL THE COMPLAINTS RECEIVED DURING 2018 AND 2019 AND SUBMIT TO FDA RETROSPECTIVE MDRS FOR THE REPORTABLE EVENTS (WITH REFERENCE TO ORIGINAL MDR REPORT #8030107-2020-00028 FILED BY DEGANIA SILICONE LTD.).

    Description of Event or Problem · 1

    THIS IS A RETROSPECTIVE REVIEW OF COMPLAINT 2018-2019 CUSTOMER TEXT: "FOR THE THIRD TIME, THE CATHETER HAS SLID OUT AND IN THE BALLOON IT HAS LIKE A PUNCTURE SITE. THE CUSTOMER WANTS TO KNOW IF THIS PROBLEM IS KNOWN. UNFORTUNATELY, NO PATTERN AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962552 FOLEY CATHETER FOLEY CATHETER KOD DEGANIA MEDICAL DEVICES PVT. LTD 14 FRENCH S16000779

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization