BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCE

    MDR report key: 3093613 · Received May 1, 2013

    Report

    Report Number
    3006260740-2013-00199
    Event Type
    Injury
    Date Received
    May 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF CATHETER BREAKAGE IS CONFIRMED. THE CATHETER WAS RETURNED IN TWO SECTIONS. THE SURECUFF IS MISSING FROM THE COMPLAINT SAMPLE. GROSS AND MICROSCOPIC EXAMINATIONS REVEALED A BREAK IN THE CATHETER. THE BREAK SITE IS LOCATED 1.1 INCHES DISTAL TO THE BIFURCATION SITE. A CROSS SECTIONAL VIEW OF THE BREAK SITE SHOWS APPROXIMATELY ONE HALF OF THE TUBING TO BE JAGGED IRREGULAR AND GRANULAR. THE OTHER HALF OF THE TUBING IS SMOOTH GLOSSY AND STRIATED. THESE TRAITS ARE ASSOCIATED WITH SHARP INSTRUMENTATION SUCH AS BEING CUT WITH SCISSORS OR A SCALPEL. MATING THE TWO ENDS REVEALED A CLOSE MATCH. THE COMPLAINANT INDICATES THE LUMEN OF THE CATHETER SPLIT. THE CROSS SECTIONAL OBSERVATIONS OF THE BREAK SITE COLLABORATE WITH THE REPORTED INCIDENT. THE TUBING MAY HAVE BEEN STRETCHED BEYOND ITS ELASTIC LIMITS TO CAUSE A PARTIAL BREAK IN THE CATHETER. THE ABSENCE OF THE DACRON CUFF ALONG WITH THE PARTIAL BREAK IN THE TUBING SUGGESTS BOTH OCCURRENCES MAY HAVE HAPPENED SIMULTANEOUSLY. THE ADHESIVE RESIDUE INDICATES THE DACRON CUFF HAD BEEN ADEQUATELY SECURED TO THE CATHETER OD. IT IS POSSIBLE THIS EVENT LED TO REMOVAL OF THE DEVICE OR AN ATTEMPT TO REPAIR THE CATHETER. THE SURECUFF WAS NOT RETURNED FOR EVALUATION. AT THIS TIME EXACT MECHANISM OF THE FAILURE IS UNDETERMINED. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. 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

    CATHETER HAS BEEN IMPLANTED IN PATIENT, LUMEN OF CATHETER SPLIT. CATHETER SAMPLE REVEALS A COMPLETE BREAK DISTAL TO THE BIFURCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188921 HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCE LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention