MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 30 CM; CATHETER, PERCUTANEOUS

Model Number	IPN033090
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: during the left jugular central venous catheter placement procedure, when the guide was displaced it was frayed so two punctures were required for the patient.Three catheters were used during placement.Additional information was requested but not received at the time of this report.
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
The complaint is reported as: during the left jugular central venous catheter placement procedure, when the guide was displaced it was frayed so two punctures were required for the patient.Three catheters were used during placement.Additional information was requested but not received at the time of this report.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 30 CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13417770
• Report Number: 9680794-2022-00061
• Device Sequence Number: 14443796
• Product Code: DQY
• UDI-Device Identifier: 10801902099683
• UDI-Public: 10801902099683
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 01/12/2022

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: 01/31/2023
• Device Model Number: IPN033090
• Device Catalogue Number: CS-16402
• Device Lot Number: 14F18H0254
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• 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