BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVARRE OPTI DRAIN

    MDR report key: 11278429 · Received February 4, 2021

    Report

    Report Number
    3006260740-2021-00217
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    January 8, 2021
    Report Date
    May 21, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    GBX
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A LOT HISTORY REVIEW, A DEVICE HISTORY RECORD REVIEW AND COMPLETE MANUFACTURING REVIEW COULD NOT BE CONDUCTED FOR THE INVESTIGATION AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, TWO ELECTRONIC PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION IS CONFIRMED FOR REPORTED CRACK ISSUE AS THE CRACK WAS NOTED ON THE LUER LOCK DRAIN ACCESS REGION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. 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: G3, H6 (METHOD). H11: D4 (MEDICAL DEVICE CATALOG NUMBER AND MEDICAL DEVICE LOT NUMBER), H6 (RESULT, CONCLUSION). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME TIME POST CATHETER IMPLANT, THE DEVICE ALLEGEDLY CRACKED. 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 RECORD IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 06/2022). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST DEVICE IMPLANT, THE DEVICE ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174781 NAVARRE OPTI DRAIN DRAINAGE CATHETER GBX C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other