BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24843323 · Received April 10, 2026

    Report

    Report Number
    9680794-2026-00266
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 16, 2026
    Report Date
    March 16, 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 REPORTED ISSUE OF CRACKED LUER HUB WAS CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE UNIT OF CATHETER HUB FOR EVALUATION. THE RED LUER HUB WAS CRACKED. SEVERE CRAZING WAS NOTED. THE BLUE LUER HUB WAS OBSERVED TO HAVE JAW AND SCUFF MARKS LIKELY DUE TO THE USE OF EXTERNAL TOOLS LIKE CLAMPS. POLYMER CRAZING WAS ALSO OBSERVED ON THE BLUE LUER HUB. LEAK WAS CONFIRMED AT RED LUER HUB WHEN FUNCTIONALLY TESTED. DISCOLORATION WAS OBSERVED ON THE DEVICE. THE IFU STATES THE FOLLOWING: DO NOT USE CLAMPS OTHER THAN THOSE THAT ARE PROVIDED. USING OTHER CLAMPS MAY DAMAGE THE CATHETER. AVOID CLAMPING NEAR LUER-LOCK FITTINGS- REPEATED OVER TIGHTENING OF BLOODLINES, SYRINGES AND CAPS WILL REDUCE CONNECTOR LIFE AND COULD LEAD TO POTENTIAL CONNECTOR FAILURE. WARNING: AVOID EXCESSIVE OR PROLONGED USE OF ALCOHOL-BASED SOLUTIONS AND OINTMENTS TO CLEAN CATHETER OR SITE CARE. ADDITIONALLY, THE COMPRESSION SLEEVE WITHIN THE CAP WAS ALSO TORN AND DAMAGED. THIS IS INDICATIVE OF USER ERROR. COMPRESSION SLEEVE WAS LIKELY SANDWICHED BETWEEN JUNCTURE HUB AND COMPRESSION CAP THREADS. THE IFU ALONG WITH THE PRODUCT ALSO NOTED - PRECAUTION: ENSURE COMPRESSION SLEEVE IS SECURELY POSITIONED INSIDE THREADED COMPRESSION CAP. AVOID ATTEMPTS TO PLACE COMPRESSION SLEEVE ONTO HUB CONNECTION ASSEMBLY CANNULA AND THEN APPLY THREADED COMPRESSION CAP. INCOMPLETE COMPRESSION MAY OCCUR CAUSING CATHETER SEPARATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE LOT AND FINDINGS OF SIMILAR FAILURE MODE OF LUER HUB CRACKS WERE IDENTIFIED. THE ISSUE IS ATTRIBUTED TO THE TECOPLAST MATERIAL. IT WAS DETERMINED THAT THE OBSERVED DAMAGE IS CONSISTENT WITH DAMAGE DUE TO SOLVENT EXPOSURE. BASED ON THE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS DESIGN RELATED. FURTHER ACTIONS HAVE BEEN TAKEN UNDER TELEFLEX QUALITY SYSTEMS TO REPLACE THE HUB MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "ON (B)(6) 2026, BEFORE THE PATIENT UNDERWENT DIALYSIS ON THE MACHINE, IT WAS FOUND THAT THERE WERE CRACKS AND BL EEDING AT THE LUER HUB. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "(B)(6) 2026, BEFORE THE PATIENT UNDERWENT DIALYSIS ON THE MACHINE, IT WAS FOUND THAT THERE WERE CRACKS AND BL EEDING AT THE LUER HUB. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255760 ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM CATHETER, HEMODIALYSIS, IMPLA PPO ARROW INTERNATIONAL LLC 33F24M0039 30801902195273

    Patients

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