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

Model Number	IPN001348
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: with these catheters, we observed a rigidity more important than usual on the "tubing" of the catheter which leads to a kink linked to the clamps.When the clamp is open (in a dialysis session), it happens that the patient moves and that this kink obstructs the passage of blood and therefore stops the blood pump.Additional information received 28oct2022: the kinked is linked to the clamp when the catheter is not used.The tubing being slightly rigid, the kink persists.If the patient moves slightly during the session, the tube pinches at the kink.The clamps are moved by the teams at each session, but this is not sufficient to avoid the problem.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: with these catheters, we observed a rigidity more important than usual on the "tubing" of the catheter which leads to a kink linked to the clamps.When the clamp is open (in a dialysis session), it happens that the patient moves and that this kink obstructs the passage of blood and therefore stops the blood pump.Additional information received 28oct2022: the kinked is linked to the clamp when the catheter is not used.The tubing being slightly rigid, the kink persists.If the patient moves slightly during the session, the tube pinches at the kink.The clamps are moved by the teams at each session, but this is not sufficient to avoid the problem.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• 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: 15784846
• Report Number: 9680794-2022-00759
• Device Sequence Number: 14231443
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: 10801902127171
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141051
• 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): 10/18/2022

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
• Device Model Number: IPN001348
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: HEMODIALYSIS; HEMODIALYSIS
• Patient Sex: Unknown