MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN030891
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Associated mdr#s: 3006425876-2023-00214; 3006425876-2023-00213.
Event or Problem Description
The complaint is reported as: during the insertion of the central catheter, the guide broke during removal or it remained stuck and impossible to remove.The patient could not have the catheter inserted and there was a delay in the treatment.It was reported the issue occurred with 3 devices on the same patient.No medical intervention was required and there was no consequence for the patient.The patient's condition is reported to be "stable".
Event or Problem Description
The complaint is reported as: during the insertion of the central catheter, the guide broke during removal or it remained stuck and impossible to remove.The patient could not have the catheter inserted and there was a delay in the treatment.It was reported the issue occurred with 3 devices on the same patient.No medical intervention was required and there was no consequence for the patient.The patient's condition is reported to be "stable".
Additional Manufacturer Narrative
(b)(4).Associated mdr#s: 3006425876-2023-00214; 3006425876-2023-00212; 3006425876-2023-00213.The customer provided one photo for analysis.The customer report of a kinked guide wire could be confirmed by the photo.However, full visual inspection could not be performed without the complete sample returned for analysis.The customer returned the product lidstock for evaluation.Neither the guide wire nor the catheter were returned for analysis.Visual inspection could not be performed as only the product lidstock was returned for analysis.A device history record review was performed with no relevant findings.The customer report of guide wire damage was confirmed based on the customer provided photo.The image shows a used guide wire kinked in several locations.However, only the product lidstock was returned for analysis.A device history record review was performed with no relevant findings.Based on these circumstances, and without the complete sample returned for analysis, the root cause for this complaint could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 8FR 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: 16479727
• Report Number: 3006425876-2023-00212
• Device Sequence Number: 3150848
• Product Code: DQY
• UDI-Device Identifier: 00801902000231
• UDI-Public: 00801902000231
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 05/31/2025
• Device Model Number: IPN030891
• Device Catalogue Number: CV-15802
• Device Lot Number: 71F20M1372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown