BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PONSKY DUAL PORT FEEDING ADAPTOR, 20F

    MDR report key: 11863273 · Received May 21, 2021

    Report

    Report Number
    3006260740-2021-01918
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    March 31, 2021
    Report Date
    August 5, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: ONE PONSKY DUAL PORT FEEDING TUBE ADAPTER WAS RETURNED FOR EVALUATION. GROSS VISUAL EVALUATION WAS PERFORMED. THE MEDICATION PORT WAS NOTED TO BE OPEN AND THE CAPS ON THE DEVICE APPEARED INTACT. BASED ON THE SAMPLE EVALUATION, THE INVESTIGATION IS UNCONFIRMED FOR THE LOOSE CAP ISSUE AS THE CAP ON THE LARGE PORT WAS ABLE TO BE CLOSED AND OPENED WITHOUT ISSUE; THE CAP DID NOT APPEAR LOOSE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. 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: H6 (RESULT, 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE CAP WAS ALLEGEDLY BECAME LOOSE AND QUICKLY CAME OFF AND GOT WET. 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 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 DURING THE PROCEDURE, THE CAP WAS ALLEGEDLY BECAME LOOSE AND QUICKLY CAME OFF AND GOT WET. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758877 PONSKY DUAL PORT FEEDING ADAPTOR, 20F FEEDING DEVICE KNT C.R. BARD, INC. (BASD) -3006260740 000333 HUCU1535 10801741080934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other