BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE 5F SINGLE-LUMEN POLYURETHANE CATHETER WITH SURECUFF INGROWTH CUFF MICR

    MDR report key: 6080794 · Received November 4, 2016

    Report

    Report Number
    3006260740-2016-00584
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    September 20, 2016
    Report Date
    October 5, 2016
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036583
    PMA / PMN Number
    K050185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A HOLE IN THE CATHETER TUBING WAS CONFIRMED, BUT THE EXACT CAUSE IS UNKNOWN DUE TO THE CONDITION OF THE RETURNED SAMPLE. FOUR PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR INVESTIGATION. EACH PHOTOGRAPH SHOWS GLOVED HANDS HOLDING THE CATHETER BY THE MOLDED WING AND THE CATHETER TUBING DISTAL TO THE WING. THE CATHETER IS BEING BENT AND FLEXED JUST DISTAL TO THE MOLDED WING. THE MATERIAL APPEARS TO BE EMBRITTLED, CRACKED, AND DISCOLORED. IN PHOTO 3 OF 4, WHAT APPEARED TO BE A HOLE WAS VISIBLE IN THE CATHETER TUBING. IT WAS REPORTED THAT THE DOCTOR SEALED THE OPENING WITH HISTOCRYL, WHICH MOST LIKELY GAVE THE CATHETER ITS EMBRITTLED, CRACKED, AND DISCOLORED APPEARANCE. AT THIS TIME, BASED ON THE EVIDENCE PROVIDED WITH THE RETURNED SAMPLE, IT IS UNKNOWN WHAT CAUSED THE HOLE IN THE CATHETER. POTENTIAL CAUSES INCLUDE SHARP INSTRUMENT DAMAGE, MATERIAL FATIGUE, AND OVERPRESSURIZATION. THE PRODUCT IFU STATES, ¿DO NOT USE THE CATHETER IF THERE IS ANY EVIDENCE OF MECHANICAL DAMAGE OR LEAKING.¿ NO FURTHER ACTION IS REQUIRED BECAUSE THE COMPLAINANT EVENT COULD NOT BE RELATED TO A DEFICIENCY IN PRODUCT MANUFACTURE OR DEFICIENCY WHILE UNDER CORRECT PRODUCT USE. LOT NUMBER REAP1468, WHICH CORRESPONDS WITH PRODUCT CODE 4132105 (PER-Q-CATH 2 FR S/L CATHETER), DOES NOT MATCH THE COMPLAINT SAMPLE (POWERLINE 5 FR S/L MI W/SCUFF) THAT HAS BEEN IMPLICATED FOR THIS COMPLAINT INVESTIGATION. THEREFORE A LHR REVIEW CANNOT BE FACILITATED FOR THE IMPLICATED COMPLAINT SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 THE POWER LINE 5 FR MONO LUMEN WAS PLACED FOR PARENTERAL NUTRITION AT HOME. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2016 WITH THE CATHETER RUPTURED AND LEAKAGE WAS OBSERVED. THE THEN DOCTOR SEALED THE OPENING WITH HISTOCRIL AS THEY NEEDED TO KEEP THE CURRENT CATHETER IN PLACE UNTIL THE REPLACEMENT. ON (B)(6) 2016 THE CATHETER WAS REPLACED BY THE DOCTOR IN THE HOSPITAL WITH A POWER LINE 5 FR, MONO LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731448 POWERLINE 5F SINGLE-LUMEN POLYURETHANE CATHETER WITH SURECUFF INGROWTH CUFF MICR PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS REAP1468 (WRONG LOT) 00801741036583

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR