MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM; CATHETER PERCUTENEOUS

Model Number	IPN919963
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: incident occurred on (b)(6) 2024, involved a 71-year-old female patient.Patient in intensive care unit with acute renal failure and hyperlactatemia.The patient had been on dialysis for 3.5 hours, using an av-set-online plus 5008-r dialysis circuit (from another supplier) connected to a femoral 2v 12fr x 25cm 12g/12g st hemodialysis catheter from teleflex.When the dialysis was disconnected from the teleflex catheter for a scan examination, the blue part of the circuit remained "stuck" inside the blue part of the catheter.The circuit broke, leaving the connector inside the catheter.There were no clinical consequences, but the patient's dialysis catheter had to be changed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: incident occurred on (b)(6) 2024, involved a 71-year-old female patient.Patient in intensive care unit with acute renal failure and hyperlactatemia.The patient had been on dialysis for 3.5 hours, using an av-set-online plus 5008-r dialysis circuit (from another supplier) connected to a femoral 2v 12fr x 25cm 12g/12g st hemodialysis catheter from teleflex.When the dialysis was disconnected from the teleflex catheter for a scan examination, the blue part of the circuit remained "stuck" inside the blue part of the catheter.The circuit broke, leaving the connector inside the catheter.There were no clinical consequences, but the patient's dialysis catheter had to be changed.
Additional Manufacturer Narrative
(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.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM
• Common Device Name: CATHETER PERCUTENEOUS
• 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: 18667955
• Report Number: 3006425876-2024-00179
• Device Sequence Number: 7128258
• Product Code: DQY
• UDI-Device Identifier: 10801902096583
• UDI-Public: 10801902096583
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/12/2024

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: 12/20/2024
• Device Model Number: IPN919963
• Device Catalogue Number: CS-26122-F
• Device Lot Number: 71F23A1493
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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 Age: 71 YR
• Patient Sex: Female