BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NASOGASTRIC TUBE

    MDR report key: 15508503 · Received September 29, 2022

    Report

    Report Number
    1018233-2022-07533
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    June 15, 2022
    Report Date
    January 12, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    BSS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE DUE TO INSUFFICIENT INFORMATION. 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. VISUAL EVALUATION OF THE RETURNED PHOTO SAMPLE NOTED ONE (WITHOUT ORIGINAL PACKAGING), USED UNKNOWN NG TUBE. VISUAL INSPECTION OF THE PHOTO SAMPLE NOTED THE COMPLAINT IS CONSIDERED INCONCLUSIVE DUE TO THE RETURN PHOTO SAMPLE BEING UNKNOWN IF THE PRODUCT IN THE PICTURE IS A BD PRODUCT. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE PRODUCT CATALOG NUMBER FOR THIS DEVICE IS UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEFT HIP JP DRAIN WAS REMOVED BY THE DOCTOR AND NOTED THAT THE JP TIP WAS MISSING, THUS RETAINING IN THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15JUN2022, IT WAS REPORTED THAT THE SERIOUS DEFECT WAS FOUND IN THE NASOGASTRIC TUBING AND THIS WAS THE DEVICE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEFT HIP JP DRAIN WAS REMOVED BY THE DOCTOR AND NOTED THAT THE JP TIP WAS MISSING, THUS RETAINING IN THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15JUN2022, IT WAS REPORTED THAT THE SERIOUS DEFECT WAS FOUND IN THE NASOGASTRIC TUBING AND THIS WAS THE DEVICE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615845 UNKNOWN NASOGASTRIC TUBE UNKNOWN NASOGASTRIC TUBE BSS C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other