BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PICC

    MDR report key: 19639830 · Received June 28, 2024

    Report

    Report Number
    3006260740-2024-03362
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 7, 2024
    Report Date
    August 30, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    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. THE COMPLAINT OF A DAMAGED CATHETER IS INCONCLUSIVE DUE TO THE STATE OF THE RETURNED SAMPLE. ONE PHOTOGRAPH OF A SINGLE LUMEN POWERPICC WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPH SHOWED THAT THE CATHETER WAS WORN AND DISCOLORED, BUT NO DAMAGE OR DETERIORATION OF THE CATHETER MATERIAL ITSELF COULD BE SEEN IN THE RETURNED PHOTOGRAPH. INSPECTION OF THE RETURNED PHOTOGRAPH WAS INSUFFICIENT TO IDENTIFY THE ALLEGED ISSUE OR A ROOT CAUSE OF THE REPORTED ISSUE. THEREFORE, THIS COMPLAINT IS INCONCLUSIVE AT THIS TIME. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT HAS HIS PICC LINE IN COMING UP TO 3 YEARS. THE HOME HEALTH NURSE IS CONCERNED OF THE INTEGRITY OF THE EXTERNAL TUBE AND "WING" STARTING TO DETERIORATE. THE PATIENT HAD A RECENT CXR AND SHOWED THAT THE TIP IS IN CAJ. THE LINE IS PATENT, WITH GOOD BLOOD RETURN AND FLUSHING FREELY. NO LEAKAGE NOTED TO THE EXTERNAL PART OF THE PICC. LOOKS LIKE THE WING PART HAVE THE ORANGE TINGE COLOR. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT HAS HIS PICC LINE IN COMING UP TO 3 YEARS. THE HOME HEALTH NURSE IS CONCERNED OF THE INTEGRITY OF THE EXTERNAL TUBE AND ¿WING¿ STARTING TO DETERIORATE. THE PATIENT HAD A RECENT CXR AND SHOWED THAT THE TIP IS IN CAJ. THE LINE IS PATENT, WITH GOOD BLOOD RETURN AND FLUSHING FREELY. NO LEAKAGE NOTED TO THE EXTERNAL PART OF THE PICC. LOOKS LIKE THE WING PART HAVE THE ORANGE TINGE COLOR. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206314 BARD PICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other