BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT PICC WITH SHERLOCK (TLS) 4F

    MDR report key: 4945163 · Received July 24, 2015

    Report

    Report Number
    3006260740-2015-00336
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Report Date
    July 7, 2015
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJS
    PMA / PMN Number
    K063240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFO AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFO, THE COMPLAINANT/ REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR, AT THIS TIME, FOR EVAL. A LOT HISTORY REVIEW (LHR) OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THESE LOT NUMBERS.

    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), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE REPORTED INCIDENT OF A KNOT IN THE GUIDEWIRE WAS CONFIRMED, BUT THE EXACT CAUSE OF THE COMPLAINT IS UNKNOWN. THE FLEXURA GUIDEWIRE WAS RECEIVED WITH AN OVERHAND KNOT IN THE FLOPPY COILED END OF THE WIRE. THE DISTAL END OF THE GUIDEWIRE EXTENDS 1MM FROM THE KNOT. A MICROSCOPIC EXAMINATION OF THE GUIDEWIRE REVEALED SPACES BETWEEN ADJACENT COILS AT THE KNOT. A TACTUAL INVESTIGATION REVEALED THAT THE COIL WIRE WAS INTACT OVER THE CORE WIRE. IT WAS REPORTED THAT THE GUIDEWIRE COULDN¿T BE ADVANCED DURING USE. IT IS POSSIBLE THAT THE WIRE INADVERTENTLY FOLDED OVER ITSELF AND WAS TWISTED INTO A KNOT WITHIN THE VEIN. NO MANUFACTURING RELATED DEFECTS WERE NOTED ON THE COMPLAINT SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RN PUT IN PICC, NOTHING ABNORMAL WITH PT OR FLUSHING OF LINE PREVIOUS TO INSERTION. REPORTED COULDN'T ADVANCE GUIDEWIRE FOR MICRO. REMOVED NEEDLE AND THEN REMOVED INTRODUCER. THE GUIDEWIRE WAS ALLEGEDLY KNOTTED AT THE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484175 GROSHONG NXT PICC WITH SHERLOCK (TLS) 4F LJS BARD ACCESS SYSTEMS INC. REYK0375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention