BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER

    MDR report key: 10805950 · Received November 7, 2020

    Report

    Report Number
    3005483737-2020-00031
    Event Type
    Malfunction
    Date Received
    November 7, 2020
    Report Date
    November 7, 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

    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 ACTIONS 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. SINCE THE SAMPLE IS UNAVAILABLE AND THE REVIEW OF THE BATCH HISTORY RECORDS AND RETAIN SAMPLES DID NOT DETECT ANY NON-CONFORMITY, WE ARE UNABLE TO JUSTIFY THE COMPLAINT. THE BURST OF THE BALLOONS COULD BE USER RELATED. THE COMPLAINT WAS NOT JUSTIFIED.

    Description of Event or Problem · 1

    THIS IS A RETROSPECTIVE REVIEW OF COMPLAINT 2018-2019 CUSTOMER TEXT, "ACCORDING TO THE REPORTER, IN ONE PATIENT, THE BALLOON CATHETER BURST SEVERAL TIMES. THIS PATIENT IS GIVEN THE MEDICATION RIFAMPICIN (BACTERICIDAL ANTIBIOTIC). SINCE THEY HAVE NO OTHER PROBLEMS WITH THIS PRODUCT, THE QUESTION IS, WHETHER THE BURSTING OF THE BALLOON IS RELATED TO THE MEDICATION ADMINISTERED". NO SAMPLE, AND NO PICTURE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270996 FOLEY CATHETER FOLEY CATHETER KOD DEGANIA MEDICAL DEVICES PVT. LTD 16 FRENCH S17002034

    Patients

    Seq Age Sex Outcome Treatment
    1