BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER, &

    MDR report key: 8323206 · Received February 8, 2019

    Report

    Report Number
    3006260740-2019-00201
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 9, 2019
    Report Date
    March 7, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741155017
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF CATHETER DISCOLORATION WAS CONFIRMED; HOWEVER, THE ROOT CAUSE WAS NOT IDENTIFIED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 5FR D/L POWERPICC SOLO CATHETER. USAGE RESIDUES WERE OBSERVED THROUGHOUT THE SAMPLE. BOTH EXTENSION TUBES APPEARED DISCOLORED. FOLLOWING LONGITUDINAL BISECTION OF ONE TUBE WITHIN THE DISCOLORED REGION, INSPECTION OF THE INSIDE SURFACE REVEALED THE DISCOLORATION TO BE MORE EXTENSIVE. MICROSCOPIC INSPECTION SAMPLE CONFIRMED THAT THE MATERIAL OF THE EXTENSION TUBES WAS DISCOLORED. THE INSIDE SURFACE WAS SCRAPED USING AN INSTRUMENT CONFIRMED THAT THE DISCOLORATION PERMEATED THE EXTENSION TUBING MATERIAL. THE OBSERVED MATERIAL DISCOLORATION APPEARED TO BE MORE SEVERE ON THE INSIDE, SUGGESTING THAT AN INFUSATE OR COMBINATION OF INFUSATES MAY HAVE CONTRIBUTED; HOWEVER, THE SOURCE OF THE DISCOLORATION COULD NOT BE IDENTIFIED. CONSEQUENTLY THIS COMPLAINT IS CONFIRMED AS ¿CAUSE UNKNOWN¿ AT THIS TIME. A LOT HISTORY REVIEW (LHR) OF RECW1720 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSION LEG TUBING TURN BLACK ON BOTH LUMENS. IT WAS STATED THE ONLY MEDICATIONS THAT WERE INFUSED WERE CEFTRIAXONE 2G QHS AND NS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF RECW1720 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTENSION LEG TUBING TURN BLACK ON BOTH LUMENS. IT WAS STATED THE ONLY MEDICATIONS THAT WERE INFUSED WERE CEFTRIAXONE 2G QHS AND NS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112365 POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER, & CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A RECW1720 00801741155017

    Patients

    Seq Age Sex Outcome Treatment
    1