BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PONSKY DUAL PORT FEEDING ADAPTOR, 20F

    MDR report key: 10612704 · Received October 1, 2020

    Report

    Report Number
    3006260740-2020-03398
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 8, 2020
    Report Date
    December 16, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KNT
    UDI-DI
    10801741080934
    PMA / PMN Number
    K915841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW:THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER AND THIS LOT MEETS ALL RELEASE CRITERIA. THE MANUFACTURING REVIEW DID NOT INDICATE ANY POSSIBLE MANUFACTURING ISSUE THAT COULD BE RELATED TO THE REPORTED EVENT. INVESTIGATION SUMMARY:ONE DUAL PORT FEEDING ADAPTER WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL EVALUATIONS WERE PERFORMED. THE INVESTIGATION IS CONFIRMED FOR FLUID LEAK AS DURING FUNCTIONAL TESTING, THE DEVICE WAS INFUSED THROUGH BOTH PORTS WITH WATER USING AN IN-HOUSE 10ML SYRINGE; NO LEAKS WERE NOTED AND BOTH THE PORTS WERE THEN SEALED AND AN IN-HOUSE SYRINGE WAS LOADED INTO THE DISTAL END OF THE FEEDING TUBE ADAPTER AND LIGHT PRESSURE WAS APPLIED; A LEAK WAS NOTED FROM THE LARGER PORT.A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW:A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4(EXPIRY DATE: 12/2099),G4 H11: H6(RESULT AND CONCLUSION) H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST FEEDING DEVICE IMPLANT, THE ADAPTER OF THE DEVICE ALLEGEDLY WAS LEAKING. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND THE EVALUATION IS STILL PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 12/2099).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST FEEDING DEVICE IMPLANT, THE ADAPTER OF THE DEVICE ALLEGEDLY WAS LEAKING. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081123 PONSKY DUAL PORT FEEDING ADAPTOR, 20F FEEDING DEVICE KNT BARD ACCESS SYSTEMS 000333 HUDN2175 10801741080934

    Patients

    Seq Age Sex Outcome Treatment
    1