BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NG TUBE W/OUT PREVENT FILTER

    MDR report key: 16564749 · Received March 17, 2023

    Report

    Report Number
    1018233-2023-01819
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 8, 2023
    Report Date
    May 25, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    BSS
    UDI-DI
    00801741052262
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "INADEQUATE MATERIAL SELECTION, DESIGN IS INADEQUATE". IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 16 FRENCH BARD NASOGASTRIC SUMP TUBE WAS PLACED AND ATTEMPTED TO AUSCULTATE AIR IN THE BELLY. AT THAT POINT, WHEN PLACED TO SUCTION, THE CAREGIVERS NOTED A SMALL HOLE IN THE TUBING NEAR THE EXHAUST PIPE WHERE JUNCTION OF TUBE AT DISTAL SIDE FROM PATIENT. AS PER FOLLOW UP VIA EMAIL ON (B)(6) 2023, IT WAS REPORTED THAT THE LOT FOR THE DEVICE WAS NGGS1366. THERE WAS NO PATIENT IMPACT AND THE DEVICE WAS DISPOSED OF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 16 FRENCH BARD NASOGASTRIC SUMP TUBE WAS PLACED AND ATTEMPTED TO AUSCULTATE AIR IN THE BELLY. AT THAT POINT, WHEN PLACED TO SUCTION, THE CAREGIVERS NOTED A SMALL HOLE IN THE TUBING NEAR THE EXHAUST PIPE WHERE JUNCTION OF TUBE AT DISTAL SIDE FROM PATIENT. AS PER FOLLOW UP VIA EMAIL ON 13MAR2023, IT WAS REPORTED THAT THE LOT FOR THE DEVICE WAS NGGS1366. THERE WAS NO PATIENT IMPACT AND THE DEVICE WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825720 NG TUBE W/OUT PREVENT FILTER NASOGASTRIC TUBE BSS C.R. BARD, INC. (COVINGTON) -1018233 0042160 NGGS1366 00801741052262

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other