MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN030779
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported it was difficult to advance the catheter on the guide.The catheter was blocked and that kinked the guide.The catheter was removed and the same guide was used to insert a new catheter at the same insertion site.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported it was difficult to advance the catheter on the guide.The catheter was blocked and that kinked the guide.The catheter was removed and the same guide was used to insert a new catheter at the same insertion site.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with one relevant finding identified.For material mcz-15853-008a, lot 72c20a0140, a non-conformance was initiated for to address the issue of "swg does not go freely throughout juncture hub".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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• 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: 13581452
• Report Number: 3006425876-2022-00167
• Device Sequence Number: 4369065
• Product Code: DQY
• UDI-Device Identifier: 10801902029017
• UDI-Public: 10801902029017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/03/2022

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 Expiration Date: 11/30/2024
• Device Model Number: IPN030779
• Device Catalogue Number: CS-15853
• Device Lot Number: 71F20B0830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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
• Patient Sex: Unknown