MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-25123-F
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	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: swg resistance/kinking.The issue was identified during use on a patient but there were no adverse reactions reported.The patient was reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of a kinked guide wire was confirmed through investigation of the returned sample.The guide wire contained multiple kinks along the body.The ars was not returned for analysis.Despite this, the guide wire passed relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.Based on the customer report and the sample received, the appearance of the damage is consistent with unintentional use error.However, without the ars returned for analysis, the potential root cause cannot be determined.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: swg resistance/kinking.The issue was identified during use on a patient but there were no adverse reactions reported.The patient was reported as fine.
Additional Manufacturer Narrative
Qn #: (b)(4).Udi related data quality updates only.Section d.4.-(udi)# corrected to (b)(4).The customer report of a kinked guide wire was confirmed through investigation of the returned sample.The guide wire contained multiple kinks along the body.The ars was not returned for analysis.Despite this, the guide wire passed relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.Based on the customer report and the sample received, the appearance of the damage is consistent with unintentional use error.However, without the ars returned for analysis, the potential root cause cannot be determined.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: swg resistance/kinking.The issue was identified during use on a patient but there were no adverse reactions reported.The patient was reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18037597
• Report Number: 3006425876-2023-01025
• Device Sequence Number: 12808275
• Product Code: FOZ
• UDI-Device Identifier: 00801902102300
• UDI-Public: (01)00801902102300(11)220531(17)240430(10)71F22E6327(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2023

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: 04/30/2024
• Device Catalogue Number: CS-25123-F
• Device Lot Number: 71F22E6327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 11/20/2023; Not provided
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/21/2023; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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.; NOT REPORTED.
• Patient Sex: Unknown