BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PONSKY DUAL PORT FEEDING ADAPTOR, 20F

    MDR report key: 10552574 · Received September 18, 2020

    Report

    Report Number
    3006260740-2020-03311
    Event Type
    Malfunction
    Date Received
    September 18, 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 EVALUATION WERE PERFORMED ON THE RETURNED DEVICE. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FLUID LEAK AS A LEAK WAS NOTED FROM THE LARGER PORT WHEN LIGHT PRESSURE WAS APPLIED DURING INFUSION.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(METHOD, RESULT) 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 SOME TIME POST FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY HAD A LEAK IMMEDIATELY AFTER THE FIRST USE. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (EXPIRY DATE: 12/2099).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME TIME POST FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY HAD A LEAK IMMEDIATELY AFTER THE FIRST USE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017591 PONSKY DUAL PORT FEEDING ADAPTOR, 20F FEEDING DEVICE KNT BARD ACCESS SYSTEMS 000333 HUDN2175 10801741080934

    Patients

    Seq Age Sex Outcome Treatment
    1