BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER)

    MDR report key: 9624814 · Received January 23, 2020

    Report

    Report Number
    3006260740-2020-00267
    Event Type
    Malfunction
    Date Received
    January 23, 2020
    Date of Event
    January 2, 2020
    Report Date
    April 7, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741035272
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, COMPLAINT AND LOT HISTORY, APPLICABLE PREVIOUS INVESTIGATION(S), LABELING, APPLICABLE MANUFACTURING RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A CATHETER OCCLUSION WAS CONFIRMED BUT THE EXACT CAUSE COULD NOT BE DETERMINED FROM THE SAMPLE PROVIDED. ONE ASSEMBLED 4 FR GROSHONG NXT CATHETER WAS RETURNED FOR INVESTIGATION. BLOOD RESIDUE WAS PRESENT WITHIN THE CATHETER. THE SAMPLE WAS FLUSHED WITH WATER USING A 12 ML SYRINGE AND WAS FOUND TO BE FULLY OCCLUDED. MICROSCOPIC OBSERVATION OF THE VALVE REVEALED IT TO BE PARTIALLY HELD OPEN BY A DARK RESIDUE WHICH APPEARS TO BE BLOOD. NO APPARENT ISSUES WERE OBSERVED WITH THE VALVE SLIT. THE SLIT LENGTH WAS MEASURED AND WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATION. BASED ON THE PRESENCE OF RESIDUAL MATERIAL BETWEEN THE VALVE, POSSIBLE CONTRIBUTING FACTORS INCLUDE CATHETER MAINTENANCE, VALVE ISSUE, AND BLEED BACK. IT COULD NOT BE DETERMINED IF THE RESIDUE BETWEEN THE VALVE WAS THE CAUSE OF THE OCCLUSION OR IF THE RESIDUE WAS AN EFFECT OF THE ISSUE; THEREFORE, THE COMPLAINT IS CONFIRMED, CAUSE UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) STATE, "FOR INTERMITTENT USE, FLUSH THE CATHETER WITH SALINE ONCE EACH WEEK OR AFTER EACH USE. NOTE: WHEN INFUSION VOLUME IS A CONCERN IN SMALL OR PEDIATRIC PATIENTS, FLUSH WITH 3ML PER LUMEN. CAUTION: TO REDUCE POTENTIAL FOR BLOOD BACKFLOW INTO THE CATHETER TIP, ALWAYS REMOVE NEEDLES OR NEEDLELESS CAPS SLOWLY WHILE INJECTING THE LAST 0.5ML OF SALINE." A LOT HISTORY REVIEW (LHR) OF REBQ1031 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER HAD OBSTRUCTION DURING PULSED FLUSHING, WHEN IT HAD ALREADY INFUSED 5ML 0,9 % SODIUM CHLORIDE, PRESENTED RESISTANCE BEFORE ADMINISTERING THE MEDICATION. CLEARANCE MANEUVERS WERE PERFORMED, BUT WITHOUT SUCCESS. IT WAS NECESSARY TO REMOVE THE CATHETER FROM THE PATIENT. CATHETER INSERTION DATE: (B)(6) 2018. ACCORDING TO INFORMATION GATHERED, THERE WAS NO CHANGE IN THE NURSING STAFF, THE SAME PROFESSIONALS CONTINUE TO MANIPULATE THE CATHETER, BOTH IN THE PASSAGE AND MAINTENANCE OF THE CATHETER. THE PATIENT DID NOT HAVE EXCESS PRESSURE FOR THE VALVE TO OPEN BY ITSELF. AS IT IS HAPPENING WITH SEVERAL CATHETERS, IT COULD POSSIBLE BE THE CONNECTOR THAT IS OPENING THE GROSHONG VALVE. CUSTOMER SENT ONE SAMPLE OF A VALVE CONNECTOR THAT THEY USE IN THE INSTITUTION FOR ALL PICCS. (BRAND: LA VIA. MANUFACTURED BY: WENZHOU KLF MEDICAL PLASTICS CO. LTD.). THE CUSTOMER REPORTED THAT THIS ISSUE IS FREQUENT AND THINKS THAT THE CATHETER VALVE IS THE PROBLEM. THE SALES REP SAYS THAT THE CONNECTOR COULD BE CONTRIBUTING TO THAT. THE CUSTOMER ALSO SAYS THE CONNECTOR HAS NEUTRAL PRESSION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REBQ1031 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER HAD OBSTRUCTION DURING PULSED FLUSHING, WHEN IT HAD ALREADY INFUSED 5ML 0,9 % SODIUM CHLORIDE, PRESENTED RESISTANCE BEFORE ADMINISTERING THE MEDICATION. CLEARANCE MANEUVERS WERE PERFORMED, BUT WITHOUT SUCCESS. IT WAS NECESSARY TO REMOVE THE CATHETER FROM THE PATIENT. CATHETER INSERTION DATE: (B)(6) 2018. ACCORDING TO INFORMATION GATHERED, THERE WAS NO CHANGE IN THE NURSING STAFF, THE SAME PROFESSIONALS CONTINUE TO MANIPULATE THE CATHETER, BOTH IN THE PASSAGE AND MAINTENANCE OF THE CATHETER. THE PATIENT DID NOT HAVE EXCESS PRESSURE FOR THE VALVE TO OPEN BY ITSELF. AS IT IS HAPPENING WITH SEVERAL CATHETERS, IT COULD POSSIBLE BE THE CONNECTOR THAT IS OPENING THE GROSHONG VALVE. CUSTOMER SENT ONE SAMPLE OF A VALVE CONNECTOR THAT THEY USE IN THE INSTITUTION FOR ALL PICCS. (BRAND: LA VIA. MANUFACTURED BY: WENZHOU KLF MEDICAL PLASTICS CO. LTD.). THE CUSTOMER REPORTED THAT THIS ISSUE IS FREQUENT AND THINKS THAT THE CATHETER VALVE IS THE PROBLEM. THE SALES REP SAYS THAT THE CONNECTOR COULD BE CONTRIBUTING TO THAT. THE CUSTOMER ALSO SAYS THE CONNECTOR HAS NEUTRAL PRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84579 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REBQ1031 00801741035272

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR