BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT 5 FR D/L PICC 55 CM BASIC KIT

    MDR report key: 6487927 · Received April 12, 2017

    Report

    Report Number
    3006260740-2017-00403
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 22, 2017
    Report Date
    May 16, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741035401
    PMA / PMN Number
    K023374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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, FREQUENCY 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 A CATHETER LEAK WAS CONFIRMED AND THE CAUSE APPEARS TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS A 5FR D/L GROSHONG PICC. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE OCCURS DUE TO CYCLIC KINKING OF THE CATHETER TUBE IN WHICH PHYSIOLOGICAL, PLACEMENT, USAGE, AND MECHANICAL FACTORS MAY GRADUALLY FORM A CRACK(S) IN THE CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND A SPLIT WAS OBSERVED ADJACENT TO THE BIFURCATION ON THE CATHETER TUBING. THE CATHETER SPLIT WAS TYPICAL OF FLEXURAL FATIGUE, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: A LONGITUDINALLY-ALIGNED SPLIT WHICH WAS CENTERED ABOUT A PREFERENTIAL KINK IN THE CATHETER. FRACTURE EDGES WHICH WERE ROUNDED AND POLISHED DUE TO REPEATED MATERIAL WEAR THE OBSERVED DAMAGE SUGGESTED REPEATED SHARP KINKING NEAR THE BIFURCATION JOINT. AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. REFERENCE FAQIR 990179 FOR FURTHER INFORMATION ABOUT THIS FAILURE TYPE.

    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. 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 BY THE FACILITY THAT THERE WAS A LEAK BY THE WHITE PART OF THE CONNECTOR. NO REPORTED HARM TO PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT THERE WAS A LEAK BY THE WHITE PART OF THE CONNECTOR. NO REPORTED HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269802 GROSHONG NXT 5 FR D/L PICC 55 CM BASIC KIT PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS UNK 00801741035401

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR