MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number	IPN919794
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the catheter malfunctioned during dialysis.The flow lines were connected properly.But the alarm rang.Despite reversing the lines, the flow remained insufficient.The volume of blood treated was insufficient.It was reported that there was a poor purification blood quality because of the issue.Additional information has been requested from the account regarding the condition of the patient.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: the catheter malfunctioned during dialysis.The flow lines were connected properly.But the alarm rang.Despite reversing the lines, the flow remained insufficient.The volume of blood treated was insufficient.It was reported that there was a poor purification blood quality because of the issue.Additional information has been requested from the account regarding the condition of the patient.
Additional Manufacturer Narrative
(b)(4).The customer returned one hemodialysis catheter for analysis.Definite signs of use in the form of biological material were observed.Initial visual analysis revealed no obvious defects or anomalies.Based on the dhr finding identified, the catheter was cross sectioned and dimensionally inspected via a microscope.Microscopic analysis of the catheter extrusion diameter confirmed that it was not within the specification limits per the catheter drawing.The overall length of the catheter measured 150mm which is within the specification limits of 147mm - 167mm per the catheter product drawing.The catheter was then cross sectioned to analyze the outer diameter and the inner diameter widths.The outer diameter from two points were measured, and slight ovality was observed.The catheter outer diameters measured 4.699mm and 4.4958mm, of which 4.4958mm is not within the specification limits of 4.62mm - 4.72mm per the extrusion graphic.Additionally, the width of the first lumen measured 1.27mm which is not within the specification limits of 1.42mm - 1.52mm per the extrusion graphic.The width of the second lumen measured 1.8796mm which is within the specification limits of 1.86mm - 1.96mm per the extrusion graphic.The extension lines of the catheter were flushed using a lab inventory syringe, and both lumens flushed as intended.Performed per ifu statement "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the extension lines were tested for liquid leakage per amrq-000162 rev.07 (bs en iso 10555-1 annex c) which states that no liquid leakage should form in one or more falling drops of water when tested at 300-320kpa for 30 seconds.Each extension line was separately attached to the leak tester, the distal tip of the catheter was occluded, and the leak tester was turned to 300 kpa for 30 seconds.No leaks were found anywhere on the catheter body or extension lines.A device history record review was performed, and a relevant finding was identified.A non-conformance was initiated for lot 72c22c0448 to address the issue of "incorrect lumen diameter".The ifu provided with this kit informs the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.".The customer report of a blocked catheter could not be confirmed as part of this complaint investigation.However, dimensional inspection of the returned catheter revealed that the catheter did not pass all relevant dimensional requirements.The width of the inner lumen was found to out of spec which could have potentially contributed to the reported event that "the flow remained insufficient" in the catheter.Therefore, based on the customer report and sample received, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Additional Manufacturer Narrative
Qn# (b)(4).Udi related data quality updates only.Section d.4.-(udi)# corrected to (b)(4).The customer returned one hemodialysis catheter for analysis.Definite signs of use in the form of biological material were observed.Initial visual analysis revealed no obvious defects or anomalies.Based on the dhr finding identified, the catheter was cross sectioned and dimensionally inspected via a microscope.Microscopic analysis of the catheter extrusion diameter confirmed that it was not within the specification limits per the catheter drawing.The overall length of the catheter measured 150mm which is within the specification limits of 147mm - 167mm per the catheter product drawing.The catheter was then cross sectioned to analyze the outer diameter and the inner diameter widths.The outer diameter from two points were measured, and slight ovality was observed.The catheter outer diameters measured 4.699mm and 4.4958mm, of which 4.4958mm is not within the specification limits of 4.62mm - 4.72mm per the extrusion graphic.Additionally, the width of the first lumen measured 1.27mm which is not within the specification limits of 1.42mm - 1.52mm per the extrusion graphic.The width of the second lumen measured 1.8796mm which is within the specification limits of 1.86mm - 1.96mm per the extrusion graphic.The extension lines of the catheter were flushed using a lab inventory syringe, and both lumens flushed as intended.Performed per ifu statement "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the extension lines were tested for liquid leakage per amrq-000162 rev.07 (bs en iso 10555-1 annex c) which states that no liquid leakage should form in one or more falling drops of water when tested at 300-320kpa for 30 seconds.Each extension line was separately attached to the leak tester, the distal tip of the catheter was occluded, and the leak tester was turned to 300 kpa for 30 seconds.No leaks were found anywhere on the catheter body or extension lines.A device history record review was performed, and a relevant finding was identified.A non-conformance was initiated for lot 72c22c0448 to address the issue of "incorrect lumen diameter".The ifu provided with this kit informs the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture." the customer report of a blocked catheter could not be confirmed as part of this complaint investigation.However, dimensional inspection of the returned catheter revealed that the catheter did not pass all relevant dimensional requirements.The width of the inner lumen was found to out of spec which could have potentially contributed to the reported event that "the flow remained insufficient" in the catheter.Therefore, based on the customer report and sample received, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: the catheter malfunctioned during dialysis.The flow lines were connected properly.But the alarm rang.Despite reversing the lines, the flow remained insufficient.The volume of blood treated was insufficient.It was reported that there was a poor purification blood quality because of the issue.Additional information has been requested from the account regarding the condition of the patient.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17849925
• Report Number: 3006425876-2023-00945
• Device Sequence Number: 6890753
• Product Code: MPB
• UDI-Device Identifier: 00801902100191
• UDI-Public: (01)00801902100191(11)221214(17)241103(10)71F23C0152(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2024
• Device Model Number: IPN919794
• Device Catalogue Number: CS-22142-F
• Device Lot Number: 71F23C0152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 12/04/2023; Not provided
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 12/05/2023; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown