MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN919472
Medical Device Problem Codes	Backflow (1064); Failure to Seal (4070)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "insertion of a dialysis catheter in the intensive care unit.When the intern inserted the catheter, and then when the nurse connected it, the clamp on the 'venous' line was not sufficiently effective.Despite clamping, the blood was beading and flowing back slowly.No problem observed on the arterial line.Doctor informed, need to check clamping and plug just after positive pressure lock." the patient's current condition is reported as "unknown" at this time.Additional information was requested from the customer; however, further details have not been provided at this time.
Additional Manufacturer Narrative
(b)(4).
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.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.
Event or Problem Description
It was reported "insertion of a dialysis catheter in the intensive care unit.When the intern inserted the catheter, and then when the nurse connected it, the clamp on the 'venous' line was not sufficiently effective.Despite clamping, the blood was beading and flowing back slowly.No problem observed on the arterial line.Doctor informed, need to check clamping and plug just after positive pressure lock.".The patient's current condition is reported as "unknown" at this time.Additional information was requested from the customer.However, further details have not been provided at this time.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21975842
• Report Number: 3006425876-2025-00434
• Device Sequence Number: 7310353
• Product Code: DQY
• UDI-Device Identifier: 00801902102119
• UDI-Public: (01)00801902102119(11)240408(17)290331(10)71F24D0052(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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 Model Number: IPN919472
• Device Catalogue Number: CS-12123-F
• Device Lot Number: 71F24D0052
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2024
• 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
• Patient Sex: Unknown