BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 FRENCH NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL

    MDR report key: 11376937 · Received February 25, 2021

    Report

    Report Number
    3006260740-2021-00475
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 22, 2021
    Report Date
    April 28, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    GBX
    PMA / PMN Number
    K951475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED. THIS IS THE FOURTH COMPLAINT REPORTED FOR THIS PRODUCT/LOT NUMBER COMBINATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THESE REPORTS. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FRACTURE AND FLUID LEAK. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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: B5, D4 (EXPIRY DATE: 08/2022). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE DAY POST DRAINAGE CATHETER PLACEMENT, THE CATHETER HUB ALLEGEDLY HAD A CRACK. IT WAS FURTHER REPORTED THAT THERE WAS AN ALLEGED LEAKAGE IN THE CATHETER. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (EXPIRY DATE: 08/2022).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMETIME POST DRAINAGE CATHETER PLACEMENT, THE CATHETER HUB ALLEGEDLY HAD A CRACK. IT WAS FURTHER REPORTED THAT THERE WAS AN ALLEGED LEAKAGE IN THE CATHETER. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275435 8 FRENCH NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL DRAINAGE CATHETER GBX C.R. BARD, INC. (BASD) -3006260740 GFDV1789

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other