MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AHDC KIT: 3-L 12 FR X 25 CM; CATHETER, HEMODIALYSIS, TRIPL

Catalog Number	CDC-16123-XP1A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the surgeon attempted to place catheter.On 2nd attempt, the red port would not aspirate well.3rd attempt was successful.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine"." associated complaints 9680794-2024-00465 and 9680794-2024-00443.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one, 3-lumen hemodialysis catheter for analysis.Signs of use in the form of biological material were observed within the catheter body.Visual inspection did not reveal any defects or anomalies.The catheter was functionally tested per the instructions-for-use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".All three lumens were flushed using a lab inventory syringe, and all lumen flushed as intended.No signs of a blockage or leaking were observed.The returned catheter was then tested per bs en iso 10555-1 section 4.7.1 (amrq-000162), which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The device was connected to a lab leak tester and pressurized to 300 kpa for 30 seconds with the distal end occluded.The extension lines were connected individually to the leak tester , and when pressurized, no catheter backflow or leaks were detected from any portion of the catheter.Therefore, the sample passed functional testing.A manual tug test confirmed all extension lines were fully secured within their respective hubs.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The customer report of a blocked catheter was not confirmed through complaint investigation of the returned sample.No defects or anomalies were observed on the returned sample.The catheter met all relevant dimensional and functional requirements including patency test and leak testing performed per iso 10555-1.A device history record review was performed, and no relevant findings were identified.Based on the customer report and sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: "the surgeon attempted to place catheter.On 2nd attempt, the red port would not aspirate well.3rd attempt was successful.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine"." associated complaints 9680794-2024-00446, 9680794-2024-00465 and 9680794-2024-00443.

• Brand Name: AHDC KIT: 3-L 12 FR X 25 CM
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPL
• 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: 19307790
• Report Number: 9680794-2024-00446
• Device Sequence Number: 6589814
• Product Code: NIE
• UDI-Device Identifier: 40801902111867
• UDI-Public: 40801902111867
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: 03/31/2025
• Device Catalogue Number: CDC-16123-XP1A
• Device Lot Number: 33F23F0679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 05/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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 Sex: Unknown