BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRAFLOGASTROSTOMY TUBE

    MDR report key: 10447080 · Received August 25, 2020

    Report

    Report Number
    3005483737-2020-00008
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Report Date
    August 25, 2020
    Manufacturer
    DEGANIA MEDICAL DEVICES PVT. LTD
    Product Code
    KNT
    PMA / PMN Number
    K070124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE DID NOT DETECT ANY NON-CONFORMITY DURING THE EVALUATION OF THE BATCH PRODUCTION RECORDS, AND THE RETAIN SAMPLES FROM THE SAME BATCH. THE ACTUAL SAMPLE EVALUATED AT DEGANIA SILICONE OUR GROUP COMPANY AND WAS FOUND OK, NO NON CONFORMITIES OBSERVED. THE G-TUBE COULD TEAR FOLLOWING IMPACT DURING USE (AGGRESSIVE MEDICATIONS OR PULLING WITH EXTENSIVE FORCE). THE COMPLAINT CONSIDERED TO BE 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 (B)(4) 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 (WITH REFERENCE TO ORIGINAL MDR REPORT # 8030107-2020-00013 FILED BY DEGANIA SILICONE LTD.)

    Description of Event or Problem · 1

    CUSTOMER'S TEXT: THE GASTROSTOMY TUBE (G-TUBE) WAS IN PLACE FOR ONE(1) DAY WHEN A TEAR IN THE G-TUBE, BETWEEN TWO OF THE PORTS, WAS IDENTIFIED. WHEN THIS WAS IDENTIFIED, THE G-TUBE WAS REMOVED AND REPLACED WITH A NEW ONE. THIS WAS FROM LOT# S18013779. THIS IS RETROSPECTIVE SUBMISSION, FOLLOWING REASSESSMENT OF OUR CUSTOMER COMPLAINTS DURING PERIOD 2018-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916735 ENTRAFLOGASTROSTOMY TUBE ENTRAFLO GASTROSTOMY FEEDING TUBE 18FR KNT DEGANIA MEDICAL DEVICES PVT. LTD 18 FRENCH S18013779

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization