MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920484
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported: "after the device placement under fluoroscopy, while testing the two ends of the catheter, the one (blue) was working perfect while at the other tip (red), one could with extremely high pressure only insert saline." customer reported only the red extension line was not working properly after placement.The device was removed and "there is a big amount of clot blocking the one of the two end holes".Another device was placed.The patient's condition is reported as fine.
Event or Problem Description
It was reported: "after the device placement under fluoroscopy, while testing the two ends of the catheter, the one (blue) was working perfect while at the other tip (red), one could with extremely high pressure only insert saline." customer reported only the red extension line was not working properly after placement.The device was removed and "there is a big amount of clot blocking the one of the two end holes".Another device was placed.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned multiple components from a hemodialysis kit including a connector assembly, catheter body, two dilators, and sheath.Visual inspection of the connector assembly and catheter body did not reveal any defects or anomalies.The outer diameter of the arterial line measured 0.1880", which is within specifications of 0.185-0.191" per extrusion graphic.The inner diameter of the arterial line measured 0.123", which is within specifications of 0.120-0.126" per extrusion graphic.The connector assembly was functionally tested per the instructions for use (ifu) provided with this kit which states, "flush hub connection assembly with sterile normal saline for injection and clamp extension lines to contain saline within lumen(s)." both lines of the connector assembly were flushed with a lab inventory water filled syringe with not leaks or blocks detected.The ifu also states, "flush catheter thoroughly with sterile normal saline for injection to remove residual blood, post-treatment and before instilling heparin." the catheter body was assembled to the connector assembly and both lines were flushed again.No leaks or blocks were detected.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit instructs the user, "open catheter clamp prior to infusion through lumen." the complaint of an extension line blocked was not able to be confirmed by a complaint investigation on the returned sample.The returned connector assembly and catheter body passed all relevant dimensional and functional testing.No blocks were able to be detected.A device history record review was performed, and no relevant findings were identified.Based on the customer description and the sample returned, no problem was found on the device.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM
• 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: 16616621
• Report Number: 9680794-2023-00206
• Device Sequence Number: 6272794
• Product Code: MSD
• UDI-Device Identifier: 10801902195224
• UDI-Public: 10801902195224
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K111117
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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 Expiration Date: 10/31/2024
• Device Model Number: IPN920484
• Device Catalogue Number: CS-15272-X
• Device Lot Number: 13F21L0628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/25/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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
• Patient Age: 80 YR
• Patient Sex: Unknown