BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 5 FR X 13 CM

    MDR report key: 14597667 · Received June 3, 2022

    Report

    Report Number
    3006425876-2022-00519
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 17, 2022
    Report Date
    May 17, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 3-LUMEN CVC FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED INSIDE THE EXTENSION LINES. AFTER FAILING FUNCTIONAL TESTING (SEE BELOW), A LEAK WAS OBSERVED AT THE JUNCTURE HUB WHEN FLUSHING THE MEDIAL EXTENSION LINE. WHEN OCCLUDING THE HOLE, WATER WAS NOT ABLE TO PASS THROUGH THE MEDIAL LUMEN. THIS INDICATES THAT A BLOCKAGE IS OCCLUDING THE LUMEN. AFTER INSERTING LONG PIN GAGES THROUGH THE LUMEN, THE BLOCKAGE WAS CLEARED. VISUAL ANALYSIS REVEALED THAT THE BLOCKAGE WAS A COMBINATION OF DRIED BIOLOGICAL MATERIAL AND A WHITE SUBSTANCE CONSISTENT WITH DRIED MEDICATION. THIS BLOCKAGE LIKELY CONTRIBUTED TO THE LEAKING ON THE JUNCTURE HUB. THE CATHETER BODY LENGTH FROM THE JUNCTURE HUB TO THE DISTAL TIP MEASURED 5 5/8" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 5 1/4"-5 3/4" PER THE CATHETER PRODUCT DRAWING. THE CATHETER BODY OUTER DIAMETER MEASURED .072" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .069"-.074" PER THE CATHETER EXTRUSION PRODUCT DRAWING. THE MEDIAL EXTENSION LINE INNER DIAMETER MEASURED .055" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .055"-.059" PER THE MEDIAL EXTRUSION PRODUCT DRAWING. THE MEDIAL EXTENSION LINE OUTER DIAMETER MEASURED .086" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .084"-.088" PER THE MEDIAL EXTRUSION PRODUCT DRAWING. A LAB INVENTORY SYRINGE FILLED WITH WATER WAS ATTACHED TO EACH OF THE EXTENSION LINES. THE PLUNGER WAS COMPRESSED. WHEN FLUSHING THE MEDIAL EXTENSION LINE, WATER WAS OBSERVED EXITING OUT OF THE HOLE IN THE JUNCTURE HUB. WHEN OCCLUDING THE HOLE, WATER WAS NOT ABLE TO PASS COMPLETELY THROUGH THE MEDIAL LUMEN. THIS INDICATES THAT A BLOCKAGE IS OCCLUDING THE MEDIAL LUMEN. AFTER CLEARING THE BLOCKAGE, WATER EXITED THE DAMAGE IN THE JUNCTURE HUB AND THE MEDIAL SKIVE HOLE. PERFORMED PER IFU STATEMENT "CHECK LUMEN PATENCY BY ATTACHING A SYRINGE TO EACH EXTENSION LINE AND ASPIRATE UNTIL FREE FLOW OF VENOUS BLOOD IS OBSERVED". A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "CHECK LUMEN PATENCY BY ATTACHING A SYRINGE TO EACH EXTENSION LINE AND ASPIRATE UNTIL FREE FLOW OF VENOUS BLOOD IS OBSERVED". THE IFU ALSO STATES, "OPEN SLIDE CLAMP PRIOR TO INFUSION THROUGH LUMEN TO REDUCE RISK OF DAMAGE TO EXTENSION LINE FROM EXCESSIVE PRESSURE". THE REPORT OF A LEAKING JUNCTURE HUB WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL AND FUNCTIONAL ANALYSIS REVEALED THAT THE JUNCTURE HUB LEAKED WHEN THE MEDIAL LUMEN WAS FLUSHED. A BLOCKAGE (DRIED BIOLOGICAL MATERIAL AND MEDICATION) WAS ALSO ENCOUNTERED WHEN FLUSHING THE MEDIAL LUMEN. THIS BLOCKAGE LIKELY CONTRIBUTED TO THE DAMAGE. THE CATHETER MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "THERE WAS A PRESENCE OF CLEAR LIQUID AT THE LEVEL OF THE BANDAGE ON THE CATHETER AND LESS MEDICINE WAS DELIVERED TO THE CHILD. WE THEN OBSERVED A SMALL CRACK ON THE BASE ON THE CATHETER SIDE WHICH COULD BE THE CAUSE OF THIS MEDICINE LEAK." IT WAS REPORTED THE PATIENT WAS "WAKING UP, WAS NOT COMFORTABLE, AND HAD DYSTONIA ATTACKS". ANOTHER CVC WAS INSERTED A FEW HOURS LATER. THE PATIENT'S STATUS WAS REPORTED TO BE "STABLE, CARE IS ONGOING". THE ISSUE WAS DETECTED APPROXIMATELY 15 DAYS AFTER CATETHER INSERTION.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "THERE WAS A PRESENCE OF CLEAR LIQUID AT THE LEVEL OF THE BANDAGE ON THE CATHETER AND LESS MEDICINE WAS DELIVERED TO THE CHILD. WE THEN OBSERVED A SMALL CRACK ON THE BASE ON THE CATHETER SIDE WHICH COULD BE THE CAUSE OF THIS MEDICINE LEAK." IT WAS REPORTED THE PATIENT WAS "WAKING UP, WAS NOT COMFORTABLE, AND HAD DYSTONIA ATTACKS". ANOTHER CVC WAS INSERTED A FEW HOURS LATER. THE PATIENT'S STATUS WAS REPORTED TO BE "STABLE, CARE IS ONGOING". THE ISSUE WAS DETECTED APPROXIMATELY 15 DAYS AFTER CATHETER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035489 ARROW CVC SET: 2-LUMEN 5 FR X 13 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F21L2352

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED| NOT REPORTED