BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 FR DL POWERPICC UPFT WITH MI AND TLS

    MDR report key: 2097288 · Received May 10, 2011

    Report

    Report Number
    3006260740-2011-00134
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 5, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF "BUBBLES & HOLES" WAS CONFIRMED, AND THE CAUSE APPEARS USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS A 5 FR D/L POWER PICC CATHETER. A WHITE/CLEAR STICKY RESIDUAL MATERIAL WAS SEEN ON BOTH EXTENSION LEGS AND HUBS. DARK RED RESIDUAL MATERIAL WAS SEEN WITHIN THE EXTENSION LEG OF THE RED LUERED LUMEN. A LONGITUDINALLY ALIGNED SPLIT APPROXIMATELY 0.5" IN LENGTH WAS SEEN BETWEEN THE 8CM AND 10CM DEPTH MARKINGS, AND ANOTHER LONGITUDINALLY ALIGNED SPLIT APPROXIMATELY 0.4" IN LENGTH WAS SEEN BETWEEN THE 43CM AND 45CM DEPTH MARKINGS. THE CATHETER APPEARED TO BE PLASTICALLY DEFORMED BETWEEN THE 23CM-25CM AND 44CM-45CM DEPTH MARKINGS, AS EVIDENCED BY BULBOUS DEFORMATION AND LOCAL DISCOLORATION OF THE CATHETER MATERIAL. THE CATHETER WAS OCCLUDED TO INFUSION THROUGH THE RED LUER, AND WOULD INFUSE SOLELY THROUGH THE SPLIT SITE WHEN INFUSED THROUGH THE PURPLE LUER. AN INFUSION ATTEMPT ON THE PURPLE LUERED LUMEN FROM THE DISTAL TIP PROVED THAT AN OCCLUSION WAS ALSO APPARENT IN THAT LUMEN. THE BULBOUS REGION BETWEEN THE 23CM-25CM WAS CUT OPEN TO INSPECT THE LUMEN. A HARDENED WHITE FOREIGN SUBSTANCE WAS FOUND IN THIS REGION. TACTILE EVALUATION SHOWED TENSILE WEAKNESS AT THE SPLIT SITES. MICROSCOPIC EXAMINATION OF THE TWO SPLIT SITES SHOWED THAT THE FRACTURE SURFACES WERE ROUGH AND GRANULAR IN APPEARANCE. THE CATHETER SPLITS ARE CHARACTERISTIC OF OVER-PRESSURIZATION DAMAGE. THE IFU PROVIDES THE FOLLOWING PRECAUTIONS REGARDING OVER-PRESSURIZATION: "DO NOT USE A SYRINGE SMALLER THAN 10ML." "EXCEEDING THE MAXIMUM FLOW RATE OF 5 ML/SEC OR THE MAXIMUM PRESSURE OF POWER INJECTORS OF 300 PSI MAY RESULT IN CATHETER FAILURE AND/OR CATHETER TIP DISPLACEMENT." "FAILURE TO ENSURE PATENCY OF THE CATHETER PRIOR TO POWER INJECTION STUDIES MAY RESULT IN CATHETER FAILURE." "CATHETERS THAT PRESENT RESISTANCE TO FLUSHING AND ASPIRATION MAY BE PARTIALLY OCCLUDED. DO NOT FLUSH AGAINST RESISTANCE..." AS BOTH LUMENS CONTAINED SUBCUTANEOUS BURST DAMAGE A SECOND FILE WAS OPENED. THIS FILE SPECIFICALLY ADDRESSES THE SPLIT BETWEEN THE 8CM AND 10CM DEPTH MARKING. A CHR OF LOT #REUL0433 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINTS FROM THIS LOT NUMBER ((B)(4)).

    Description of Event or Problem · 1

    LINE WAS PLACED (B)(6) 2011. ON (B)(6) 2011, THERE WAS NO BLOOD RETURN. STILL ABLE TO INFUSE ULTRAM IN BOTH LUMENS. THE PICC NURSES THAT PLACED THE LINE USE 10CC SYRINGES, PATIENT WAS SENT TO CRITICAL CARE AFTER PICC PLACEMENT. UNKNOWN IF CT SCAN OR SIZE SYRINGES ARE USED IN CRITICAL CARE. PATIENT HAD INCREASE ARM CIRCUMFERENCE. DOPPLER STUDY INDICATED NORMAL LIMITS. ONCE THE LINE WAS REMOVED ON (B)(6) 2011, PHYSICIAN DETERMINED NOT TO COMPLETE ANOTHER DOPPLER STUDY. PATIENT MAY HAVE BEEN TRANSFER TO HOSPICE AFTER LINE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL POWERPICC UPFT WITH MI AND TLS LJS C. R. BARD INC. (BASD) REUL0433

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention