MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS

Catalog Number	CS-24706-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that"07 nov 2023, the swg was found kinked during used on the patient.
Additional Manufacturer Narrative
(b)(4).The report that the guide wire kinked during use was not confirmed through examination of the returned sample.No defects or anomalies were observed on the returned components.The returned guide wire met all relevant dimensional and functional requirements.A device history record review did not identify any manufacturing related issues.Based these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that (b)(6) 2023, the swg was found kinked during used on the patient.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only**.
Event or Problem Description
It was reported that"07 nov 2023, the swg was found kinked during used on the patient.

• Brand Name: ARROW CVC SET: 14 GA X 6" (16 CM)
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18274636
• Report Number: 3006425876-2023-01194
• Device Sequence Number: 17876698
• Product Code: DQY
• UDI-Device Identifier: 10801902102291
• UDI-Public: (01)10801902102291(11)220517(17)240422(10)71F22E1074(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/09/2023

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: 04/22/2024
• Device Catalogue Number: CS-24706-E
• Device Lot Number: 71F22E1074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/18/2023; Not provided
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 12/20/2023; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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