BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRAFLOGASTROSTOMY TUBE

    MDR report key: 10464247 · Received August 28, 2020

    Report

    Report Number
    3005483737-2020-00014
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Report Date
    August 28, 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

    NO SAMPLES WERE AVAILABLE FOR THIS COMPLAINT. NO SPECIFIC BATCH NUMBERS WERE PROVIDED FOR THIS COMPLAINT. WE CHECKED THE CURRENT IN PROCESS LOT S18006408 WHEN THE COMPLAINT WAS RECEIVED AND THE CURRENT LOT # S20001471 FOR 16 FR G.TUBE FOR THE DIMENSIONS OF THE FUNNELS OF THE G.TUBE. THE FUNNEL DIMENSIONS FOUND TO BE CONFORMING TO THE SPECIFICATION. THE CUSTOMER DEMONSTRATING THAT THE CONNECTORS THROUGH THE PICTURES THAT THE CONNECTORS ATTACHED TO THE G.TUBES OFTEN DETACH AND CAUSE LEAKAGE OF FORMULA AND MEDICATION. WE WERE UNABLE TO FIND ANY DEVIATION FROM SPECIFICATION IN OUR G.TUBES AT OUR END. THE FUNNEL IS CONFORMING TO THE ORIGINAL DESIGN OF MEDLINE. SINCE NO DEVIATION FROM THE SPECIFICATION WAS FOUND IN THE G.TUBES, 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 # 8030107-2020-00023 FILED BY DEGANIA SILICONE LTD.)

    Description of Event or Problem · 1

    CUSTOMER'S TEXT: BASED ON TRENDING DATA, THERE WAS AN INCREASE IN OVERALL COMPLAINTS FOR THE G-TUBE FROM DEGANIA. THE GENERAL ISSUE WAS FOR LEAKING. THIS RESULTED FROM THE CAPS NOT STAYING IN PLACE OR TEARING OFF. THESE COMPLAINTS RESULTED IN MDR'S BEING FILED WITH FDA REGARDING THESE PRODUCTS. ALTHOUGH THE CUSTOMERS WERE NOT ABLE TO PROVIDE SAMPLES OR PICTURES, THIS INCREASE IN COMPLAINTS WAS GREATER THAN PREVIOUS YEARS FOR THESE ITEMS. PLEASE INVESTIGATE RETAIN SAMPLES AND PROVIDE DOCUMENTATION FOR SPECIFICATIONS REGARDING THE CAP REMOVAL FORCE AND TEARING FORCE. 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
    928489 ENTRAFLOGASTROSTOMY TUBE ENTRAFLO GASTROSTOMY FEEDING TUBE KNT DEGANIA MEDICAL DEVICES PVT. LTD 16 FRENCH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization