BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE

    MDR report key: 11757268 · Received April 30, 2021

    Report

    Report Number
    3006260740-2021-01644
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    December 24, 2020
    Report Date
    September 7, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: UPON FURTHER REVIEW, IT WAS IDENTIFIED THAT THE PRODUCT CATALOG NUMBER BELONGS TO PERIPHERAL INTERVENTION (PI) - TEMPE BUSINESS UNIT. THEREFORE, BUSINESS UNIT FOR THE COMPLAINT HAS BEEN CHANGED FROM VASCULAR ACCESS DEVICES (VAD) - SALT LAKE CITY TO PERIPHERAL INTERVENTION (PI) - TEMPE. H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: ONE 6 FR POWERLINE CATHETER WERE RETURNED. GROSS VISUAL, MICROSCOPIC VISUAL AND FUNCTIONAL EVALUATION WERE PERFORMED ON THE RETURNED DEVICE. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FRACTURE AND THE IDENTIFIED LEAK ISSUE AS A CIRCUMFERENTIAL SPLIT WAS NOTED IN THE EXTENSION TUBING INTERFACE WITH THE HUB AND THE SPLIT SURFACE APPEARED TO BE ROUGH AND EXHIBITED CRACKS/FISSURES MARKS SHOWS MATERIAL FATIGUE. HOWEVER, A LEAK WAS OBSERVED TO EMANATE FROM THE EXTENSION TUBING WHEN FLUSHING THE RED HUB. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON 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. 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 : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD CRACKS ON CENTERLINE. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT'S CENTRAL LINE HAD A CRACK. PATIENT TRAVELED HERE TO REPLACE CENTRAL LINE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647517 POWERLINE CHRONIC CATHETERS LJS C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other