BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® NASOGASTRIC SUMP TUBE

    MDR report key: 8384423 · Received March 2, 2019

    Report

    Report Number
    1018233-2019-01123
    Event Type
    Malfunction
    Date Received
    March 2, 2019
    Report Date
    April 8, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    BSS
    UDI-DI
    00801741052286
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "WARNINGS: CHECK VENT LUMEN ROUTINELY FOR REFLUX. THIS INDICATES AN OBSTRUCTED MAIN LUMEN. FAILURE TO CLEAR OBSTRUCTION AND CLEAR PREVENT FILTER MAY CAUSE GAS AND FLUID BUILD-UP IN STOMACH. THIS MAY LEAD TO ASPIRATION, WHICH MAY RESULT IN ASPIRATION PNEUMONIA AND OTHER COMPLICATIONS. DO NOT INJECT FLUID THROUGH FILTER. THIS MAY RESULT IN BLOCKAGE AND LEAKAGE OF FILTER. INSTRUCTIONS FOR ANTI-REFLUX FILTER. 1. FIRMLY SEAT THE TAPERED END OF ANTI-REFLUX FILTER IN BLUE AIR LUMEN VENT OF NASOGASTRIC TUBE. 2. INSURE 5-IN-1 ADAPTER IS SNUGLY INSERTED INTO SUCTION LUMEN TO PREVENT SUCTION LOSS. 3. IF GASTRIC REFLUX IN VENT LUMEN IS OBSERVED, CLEAR THE OBSTRUCTION IN THE MAIN LUMEN BY FOLLOWING YOUR HOSPITAL'S STANDARD PROTOCOL. ATTACH SYRINGE TO LUER FITTING ON ANTI-REFLUX FILTER AND INJECT A MINIMUM OF 15CC OF AIR TO CLEAR THE BLUE AIR VENT LUMEN OF ANY GASTRIC REFLUX. DO NOT INJECT FLUID THROUGH FILTER. 4. TO CAP NASOGASTRIC TUBE WHEN TUBE IS NOT CONNECTED TO A SUCTION SOURCE INSERT TRANSPORT PLUG ON ANTI-REFLUX FILTER HOUSING INTO SUCTION LUMEN OF NASOGASTRIC TUBE. 5. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS." CORRECTIONS: D1, D2, D4, D10, G5, H3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MARKINGS ON THE NG TUBE HAD RUBBED OFF. WITHOUT THE MARKINGS, THE NURSING STAFF COULD NOT DETERMINE WHERE THE NG TUBE WAS INSERTED, OR WHERE IT SHOULD BE LOCATED. ADDITIONALLY, IT WAS ALLEGED THAT RESIDUE REMAINED IN THE FILTERS AFTER USE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MARKINGS ON THE NG TUBE HAD RUBBED OFF. WITHOUT THE MARKINGS, THE NURSING STAFF COULD NOT DETERMINE WHERE THE NG TUBE WAS INSERTED, OR WHERE IT SHOULD BE LOCATED. ADDITIONALLY, IT WAS ALLEGED THAT RESIDUE REMAINED IN THE FILTERS AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178042 BARD® NASOGASTRIC SUMP TUBE FILTERS FOR NG TUBE BSS C.R. BARD, INC. (COVINGTON) -1018233 0046000 NGCU2173 00801741052286

    Patients

    Seq Age Sex Outcome Treatment
    1