BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PONSKY DUAL PORT FEEDING ADAPTOR, 20F

    MDR report key: 12266773 · Received August 3, 2021

    Report

    Report Number
    3006260740-2021-03086
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    October 1, 2020
    Report Date
    August 18, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED LEAK ISSUE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE 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). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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 : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FEEDING TUBE PLACEMENT PROCEDURE, THE TIP OF THE DEVICE ALLEGEDLY HAD AN EXTERNAL 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 RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 12/2099).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FEEDING TUBE PLACEMENT PROCEDURE, THE TIP OF THE DEVICE ALLEGEDLY HAD AN EXTERNAL LEAK. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168301 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