BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM

    MDR report key: 24907895 · Received April 17, 2026

    Report

    Report Number
    9680794-2026-00280
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 23, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    PPO
    UDI-DI
    30801902195273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORT OF A CRACKED LUER HUB WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED SIGN IFICANT CRAZING ON BOTH LUER HUBS. MINOR SURFACE CRACKING WAS NOTED ON THE ARTERIAL LUER HUB. A SIGNIFICANT CRACK WAS OBSERVED ON THE VENOUS LUER HUB. THE THREADS ON THE VENOUS LUER HUB APPEARED WORN AND DEFORMED. AN OBSTRUCTION WAS NOTED INSIDE THE VENOUS LUER HUB. DISCOLORATION WAS NOTED ON BOTH LUER HUBS, EXTENSION LINES, AND JUNCTURE HUB. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE RETURNED DEVICE PASSED FUNCTIONAL TESTING FOR THE ARTERIAL LINE AND NO LEAKS WERE NOTED. THE VENOUS LINE WAS UNABLE TO BE FUNCTIONALLY TESTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND THERE WERE NO RELEVANT FINDINGS. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED. NO ALCOHOL IMPREGNATED CAPS WERE USED. POVIDONE-IODINE WAS USED TO DISINFECT THE CATHETER HUB. THE LUER HUB CAPS WERE NOT OVERTIGHTENED. AN INVESTIGATION HAD PREVIOUSLY BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. IT WAS DETERMINED THAT THE OBSERVED DAMAGE IS CONSISTENT WITH DAMAGE DUE TO SOLVENT EXPOSURE. A PROJECT HAS BEEN CREATED WITHIN THE TELEFLEX QUALITY SYSTEM TO REPLACE THE HUB MATERIAL. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, THE PROBABLE CAUSE IS LIKELY DESIGN RELATED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "ON (B)(6) 2026, A DIALYSIS NURSE DISCOVERED PATIENT WHO HAD BLEEDING FROM A CRACKED LUER HUB BEFORE UNDERGOING DIALYSIS. THERE WAS NO REPORTED PATIENT HARM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "ON (B)(6) 2026, A DIALYSIS NURSE DISCOVERED PATIENT WHO HAD BLEEDING FROM A CRACKED LUER HUB BEFORE UNDERGOING DIALYSIS. THERE WAS NO REPORTED PATIENT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18643 ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM CATHETER, HEMODIALYSIS, IMPLA PPO ARROW INTERNATIONAL LLC 33F25D0125 30801902195273

    Patients

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