BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRO NXT W/STRIPED CATH 4F SL BASIC JPN HANG

    MDR report key: 6894822 · Received September 26, 2017

    Report

    Report Number
    3006260740-2017-01696
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    September 3, 2017
    Report Date
    November 20, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 LEAK WAS CONFIRMED, AND IT APPEARED THAT THE CATHETER WAS DAMAGED DURING USE. THE IMPLICATED PRODUCT WAS A 4 FR S/L GROSHONG PICC. THE PRODUCT RETURNED FOR INVESTIGATION WAS A 5FR D/L GROSHONG PICC. THE PICC REVEALED EVIDENCE OF USE. A SUTURE WING WAS SECURED TO THE CATHETER AT THE 28CM DEPTH MARK. SUTURES HAD BEEN TIED THROUGH THE HOLES IN THE SUTURE WING. RESIDUE WAS OBSERVED ON THE EXTERNAL SURFACE OF THE TUBING BETWEEN THE BIFURCATION AND THE SUTURE WING. COAGULATED BLOOD RESIDUE WAS OBSERVED BEHIND EACH VALVE AT THE DISTAL END OF THE CATHETER. TEARS WERE OBSERVED IN THE MOLDED BIFURCATION JUST PROXIMAL TO THE WINGS. A MICROSCOPIC EXAMINATION OF THE TORN MATERIAL REVEALED A JAGGED AND GRANULAR SURFACE, WHICH IS CONSISTENT WITH A TEAR IN THE MATERIAL AS OPPOSED TO A CUT. A FUNCTIONAL TEST REVEALED THAT FLUID LEAKED FROM EACH LUMEN WHERE THE BIFURCATION WAS TORN. THE EVIDENCE OF USE SUGGESTS THAT THE TEARS IN THE CATHETER DEVELOPED OVER TIME AND COULD BE ASSOCIATED WITH HOW THE CATHETER WAS SECURED AND HOW THE DEVICE WAS HANDLED DURING USE. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURE WING SPLIT AND THE LEAKAGE WAS FOUND FROM BOTH OF THE EXTENSION TUBES. IT WAS STATED THAT AT THE TIME OF DAMAGE OCCURRENCE, MEDICINE WAS NOT ADMINISTERED THROUGH THE DEVICE. IT WAS REPORTED THAT THE FLUSHING OF THE DEVICE WITH A 10 ML SYRINGE WAS CONDUCTED EVERY TIME ANTIBIOTIC WAS ADMINISTERED THROUGH THE DEVICE AND FLUSHING OF THE DEVICE WAS CONDUCTED APPROXIMATELY 3 TIMES PER DAY. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURE WING SPLIT AND THE LEAKAGE WAS FOUND FROM BOTH OF THE EXTENSION TUBES. IT WAS STATED THAT AT THE TIME OF DAMAGE OCCURRENCE, MEDICINE WAS NOT ADMINISTERED THROUGH THE DEVICE. IT WAS REPORTED THAT THE FLUSHING OF THE DEVICE WITH A 10 ML SYRINGE WAS CONDUCTED EVERY TIME ANTIBIOTIC WAS ADMINISTERED THROUGH THE DEVICE AND FLUSHING OF THE DEVICE WAS CONDUCTED APPROXIMATELY 3 TIMES PER DAY. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676005 GRO NXT W/STRIPED CATH 4F SL BASIC JPN HANG PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1