MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15232-VFIE
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician identified a malfunction with the locking hub during chronic hemodialysis catheter placement at right internal jugular vein under fluoroscopy guidance.The issue was resolved by inserting a new catheter.There was no therapy delay or patient harm associated with this event.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that the physician identified a malfunction with the locking hub during chronic hemodialysis catheter placement at right internal jugular vein under fluoroscopy guidance.The issue was resolved by inserting a new catheter.There was no therapy delay or patient harm associated with this event.
Event or Problem Description
It was reported that the physician identified a malfunction with the locking hub during chronic hemodialysis catheter placement at right internal jugular vein under fluoroscopy guidance.The issue was resolved by inserting a new catheter.There was no therapy delay or patient harm associated with this event.
Additional Manufacturer Narrative
(b)(4).The customer returned one vectorflow kit for analysis.Signs of use were observed.Visual analysis revealed that the blue venous pinch clamp was deformed.The pinch clamp material was lighter in color at the bent area of clamp, indicating stress.No other defects or anomalies were observed.Manufacturing was contacted and stated that the pinch clamps are inspected during the manufacturing process.The catheter assembly is inspected , where it is verified that the component includes the pinch clamp and that the clamp is placed correctly.Additionally, the pinch clamps are inspected during a sampling inspection.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit states, "examine catheter and extension lines before and after each treatment for any signs of damage." the complaint was confirmed through investigation of the returned sample.Visual inspection revealed that the blue venous pinch clamp was deformed.The pinch clamp material was lighter in color at the bent area of clamp, indicating stress.A device history record (dhr) review was performed, and no relevant findings were identified.Manufacturing was contacted and confirmed that the pinch clamps are inspected during the manufacturing process.According to the customer report, damage was found during use.Based on the report received and the sample returned, it was determined that unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTE
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21195703
• Report Number: 9680794-2025-00050
• Device Sequence Number: 20965991
• Product Code: MSD
• UDI-Device Identifier: 10801902112801
• UDI-Public: (01)10801902112801(11)240905(17)270831(10)33F24G0169(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CS-15232-VFIE
• Device Lot Number: 33F24G0169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2025
• Supplement Date Received by Manufacturer: 02/14/2025; 11/25/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/25/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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 Age: 22 YR
• Patient Sex: Male