BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PONSKY DUAL PORT FEEDING ADAPTOR, 20F

    MDR report key: 11257562 · Received February 1, 2021

    Report

    Report Number
    3006260740-2021-00169
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 5, 2021
    Report Date
    February 9, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    KNT
    UDI-DI
    10801741080934
    PMA / PMN Number
    K915841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THIS IS THE FIRST COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT, THEREFORE A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. INVESTIGATION SUMMARY: ONE DUAL PORT FEEDING ADAPTER WAS RETURNED FOR EVALUATION. FUNCTIONAL AND GROSS VISUAL EVALUATIONS WERE PERFORMED. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FLUID LEAK AND THE IDENTIFIED PINHOLE ISSUE, AS A LEAK WAS NOTED FROM THE LARGER PORT WHEN AN IN-HOUSE SYRINGE WAS LOADED INTO THE DISTAL END OF THE FEEDING TUBE ADAPTER AND LIGHT PRESSURE WAS APPLIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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). 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME TIME POST FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY HAD FLUID LEAK. 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 RECORD IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 12/2099).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME TIME POST FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY HAD FLUID LEAK. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156855 PONSKY DUAL PORT FEEDING ADAPTOR, 20F FEEDING DEVICE KNT C.R. BARD, INC. (BASD) -3006260740 000333 HUEU1561 10801741080934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other