BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6549376 · Received May 5, 2017

    Report

    Report Number
    3006260740-2017-00581
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    March 14, 2017
    Report Date
    May 26, 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 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.

    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 4FR S/L GROSHONG NXT CLEARVUE PICC. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH CATHETER DAMAGE CAUSED BY CONTACT WITH A SHARP EDGED INSTRUMENT SUCH AS A SCALPEL. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND A 1MM SPLIT WAS OBSERVED BETWEEN THE 54CM AND 55CM DEPTH MARKINGS. MICROSCOPIC EXAMINATION OF THE CATHETER SPLIT CONFIRMED IT WAS TYPICAL OF CONTACT WITH A SHARP BLADED INSTRUMENT, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: THE FRACTURE SURFACE WAS REFLECTIVE IN NATURE AND CONTAINED A STRIATED PATTERN. THIS CAN OCCUR DUE TO PATTERN TRANSFER OF THE SHARPENED EDGE TYPICALLY FOUND ON A SCALPEL-TYPE INSTRUMENT. SHARPLY FORMED FRACTURE EDGES. PLANAR SHAPE TO THE FRACTURE SURFACE. CARE SHOULD BE TAKEN WHEN USING SHARP-EDGED INSTRUMENTS NEAR THE PRODUCT, AND THE PRODUCT INSTRUCTION FOR USE (IFU) WAS FOUND TO CONTAIN THE FOLLOWING INFORMATION WHICH MAY BE RELEVANT TO THIS TYPE OF EVENT, "AVOID ACCIDENTAL DEVICE CONTACT WITH SHARP INSTRUMENTS AND MECHANICAL DAMAGE TO THE CATHETER MATERIAL. USE ONLY SMOOTH-EDGED ATRAUMATIC CLAMPS OR FORCEPS." AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE FROM CATHETER WAS FOUND WHEN THE PATIENT WAS TRANSFERRED TO OTHER WING OF HOSPITAL AND STARTED TRANSFUSION. THE CATHETER WAS REPAIRED. NO REPORTED HARM TO PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE FROM CATHETER WAS FOUND WHEN THE PATIENT WAS TRANSFERRED TO OTHER WING OF HOSPITAL AND STARTED TRANSFUSION. THE CATHETER WAS REPAIRED. NO REPORTED HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331073 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