MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15192-X
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "doctor states that the hub in the set would not screw onto the catheter once tunnelling was completed and they were attaching the hubs.Collar was used." the device was not removed or replaced the catheter was left in situ.Another hubset was used to complete the procedure.There was no medical intervention needed.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer provided one photo for analysis.The photo shows the hub of the connector assembly, the threaded compression fitting/cap, and the compression sleeve.The customer also returned one, opened nextstep retrograde chronic hemodialysis kit including the tunneling instrument, connector assembly, compression fitting, and compression sleeve for analysis.Signs of use were observed within the threaded compression fitting/cap.Visual analysis of the threaded compression fitting/cap and connector assembly hub did not reveal any signs of "missing" threads as reported by the customer.No defects or anomalies were observed on the compression sleeve.The threaded compression fitting/cap and compression sleeve were assembled onto the connector assembly per the instructions-for-use (ifu).The ifu provided with this kit instructs the user, "slide threaded compression cap over compression sleeve towards hub connection assembly with compression sleeve seated completely inside.Thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly." the threaded compression fitting/cap and compression sleeve assembled onto the connector assembly hub as intended.No threads were visible after assembly.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user, "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." the complaint of the threaded compression fitting/cap not connecting to the connector assembly was not able to be confirmed through complaint investigation of the returned sample.Visual analysis did not reveal any "missing threads" from either the threaded compression fitting/cap nor connector assembly hub.Functional testing of the threaded compression fitting/cap and compression sleeve verified the components assembled as intended.Based on the customer report and sample received, no problem was found on the returned device.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "doctor states that the hub in the set would not screw onto the catheter once tunnelling was completed and they were attaching the hubs.Collar was used." the device was not removed or replaced the catheter was left in situ.Another hubset was used to complete the procedure.There was no medical intervention needed.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 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: 20011874
• Report Number: 9680794-2024-00791
• Device Sequence Number: 12577196
• Product Code: MSD
• UDI-Device Identifier: 00801902096289
• UDI-Public: (01)00801902096289(11)230601(17)260430(10)33F23E0564(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 04/30/2026
• Device Catalogue Number: CS-15192-X
• Device Lot Number: 33F23E0564
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown