BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT CATHETER 5F BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER)

    MDR report key: 7396214 · Received April 4, 2018

    Report

    Report Number
    3006260740-2018-00588
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    February 19, 2018
    Report Date
    May 24, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K023374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    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; THE MANUFACTURING LOT NUMBER THAT WAS PROVIDED IS INCORRECT.

    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 THE CAUSE APPEARS TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS 5 FR D/L GROSHONG NXT PICC. THE DAMAGE OBSERVED IN THE RETURNED SAMPLE WAS CHARACTERISTIC OF OVER-PRESSURIZATION (BURST) DAMAGE. THIS CAN OCCUR THROUGH THE USE OF SYRINGES SMALLER THAN 10ML, BY FLUSHING AGAINST AN OCCLUSION, OR DUE TO EXCESSIVE FORCE APPLIED DURING INFUSION PROCEDURES. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND TWO SPLITS WERE OBSERVED NEAR THE 51CM DEPTH MARK. THIS CATHETER DAMAGE WAS TYPICAL OF A BURST, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: 'S' SHAPED SPLIT. TENSILE WEAKNESS AT THE FRACTURE SITE (DUE TO MATERIAL BALLOONING PRIOR TO BURST). GRANULAR FRACTURE SURFACE TEXTURE (TYPICAL OF TEARING FAILURE MODES). AN OCCLUSION WAS OBSERVED DISTAL TO THE BURST SITE, AND THIS MAY HAVE CONTRIBUTED TO THE FAILURE. FORCEFUL FLUSHING AGAINST AN OCCLUSION CAN CAUSE THIS TYPE OF FAILURE. THE PRODUCT IFU STATES, ¿CATHETERS THAT PRESENT RESISTANCE TO FLUSHING AND ASPIRATION MAY BE PARTIALLY OR COMPLETELY OCCLUDED. DO NOT FLUSH AGAINST RESISTANCE. IF THE LUMEN WILL NEITHER FLUSH NOR ASPIRATE AND IT HAS BEEN DETERMINED THAT THE CATHETER IS OCCLUDED WITH BLOOD, A DECLOTTING PROCEDURE PER INSTITUTION PROTOCOL MAY BE APPROPRIATE.¿ AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. A LOT HISTORY REVIEW (LHR) OF REBV2486 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHEMOTHERAPY PROCEDURE, LEAK WAS ALLEGEDLY OBSERVED FROM THE RED-LUERED EXTENSION TUBE. THE CATHETER WAS NO LONGER USED AS OF (B)(6) 2018. THE SOLUTIONS THAT LEAKED WAS SALINE AND ANY OF THE ANTIBIOTIC, PREDOPA, BFLUID, OR KMG, NOT AN ANTICANCER AGENT. SUBSEQUENTLY (THE EXACT DATE OR TIME IS UNKNOWN), THE CATHETER WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY INCLUDING SKIN DAMAGE. REPORTEDLY, THE CATHETER WAS IMPLANTED VIA THE RIGHT MEDIAN CUBITAL VEIN FOR TPN ON (B)(6) 2018. DURING THE FIRST SALINE FLUSH, LEAK WAS ALLEGEDLY ALREADY OBSERVED. A 10ML SYRINGE WAS USED TO CATHETER FLUSH. THE CATHETER WASN¿T SUTURED BUT SECURED TO SKIN USING STATLOCK. ANTIBIOTIC, PREDOPA, BFLUID, AND KMG HAD BEEN INFUSED BY THE EVENT DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHEMOTHERAPY PROCEDURE, LEAK WAS ALLEGEDLY OBSERVED FROM THE RED-LUERED EXTENSION TUBE. THE CATHETER WAS NO LONGER USED AS OF (B)(6) 2018. THE SOLUTIONS THAT LEAKED WAS SALINE AND ANY OF THE ANTIBIOTIC, PREDOPA, BFLUID, OR KMG, NOT AN ANTICANCER AGENT. SUBSEQUENTLY (THE EXACT DATE OR TIME IS UNKNOWN), THE CATHETER WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY INCLUDING SKIN DAMAGE. REPORTEDLY, THE CATHETER WAS IMPLANTED VIA THE RIGHT MEDIAN CUBITAL VEIN FOR TPN ON (B)(6) 2018. DURING THE FIRST SALINE FLUSH, LEAK WAS ALLEGEDLY ALREADY OBSERVED. A 10ML SYRINGE WAS USED TO CATHETER FLUSH. THE CATHETER WASN¿T SUTURED BUT SECURED TO SKIN USING STATLOCK. ANTIBIOTIC, PREDOPA, BFLUID, AND KMG HAD BEEN INFUSED BY THE EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241168 GROSHONG NXT CATHETER 5F BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS REBV2486

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR