BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASOGASTRIC SUMP TUBE DUAL LUMEN

    MDR report key: 7094876 · Received December 7, 2017

    Report

    Report Number
    1018233-2017-06269
    Event Type
    Injury
    Date Received
    December 7, 2017
    Report Date
    December 7, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    BSS
    PMA / PMN Number
    PRE-AMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE PRODUCT FAMILY FOR THIS NASOGASTRIC TUBE PRODUCT IS UNKNOWN. THEREFORE, BARD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE NASOGASTRIC TUBE PRODUCT IFUS ARE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. (B)(4). THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION WHILE USING THE NASOGASTRIC TUBE IN (B)(6) 2016. THE COMPLAINANT REPORTED THAT THE EPISODE WAS ACUTE AND REQUIRED THE USE OF EPINEPHRINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876709 NASOGASTRIC SUMP TUBE DUAL LUMEN NASOGASTRIC TUBE BSS C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention