MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-22703-E
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: during the procedure according to ifu, md found that the guide wire was bent.So md opened up the new kit to finish the procedure.Patient was reported as fine and there was no reported patient harm or consequence.
Event or Problem Description
It was reported that: during the procedure according to ifu, md found that the guide wire was bent.So md opened up the new kit to finish the procedure.Patient was reported as fine and there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The report that the spring wire guide was kinked was confirmed through examination of the returned sample.The customer returned one opened cvc kit, including one guide wire assembly, catheter, and arrow raulerson syringe (ars) for evaluation.The end cap, a component of the guide wire assembly, was not returned.No definite signs of use were observed.Visual analysis revealed that the guide wire contained one kink towards the distal j-bend.Microscopic examination confirmed the damage.The kink on the guide wire would have been protected during packaging, shipping, and storage.Both welds were observed to be full and spherical.No other defects or anomalies were observed with the guide wire, tubing, nor the returned tray.The kink in the guide wire measured 8mm via calibrated ruler from the distal end.The overall length of the guide wire measured 456mm via calibrated ruler, which was within the specifications of 450-458mm per product drawing.The guide wire outer diameter (od) measured 0.798mm via calibrated micrometer, which was within the specifications of 0.788-0.826mm per product drawing.The guide wire was functionally tested per the instructions for use (ifu) pr ovided with this kit, which instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through the returned ars and lab inventory 18ga introducer needle subassembly and passed with little to no resistance.The catheter was also advanced over the guide wire and the guide wire passed with little to no resistance.A manual tug test confirmed both welds were intact.A device history record review was performed, and no relevant findings were identified.During normal assembly, the kinked portion of the guidewire are protected within the protective tubing of the advancer assembly, however, the end cap was missing from the assembly.Based on the customer report and sample received, the potential root cannot be determined as it could not be confirmed when the damage occurred.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: during the procedure according to ifu, md found that the guide wire was bent.So md opened up the new kit to finish the procedure.Patient was reported as fine and there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only section d.4.-unique identifier (udi)# corrected to (b)(4).

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18245663
• Report Number: 3006425876-2023-01152
• Device Sequence Number: 20475885
• Product Code: FOZ
• UDI-Device Identifier: 00801902102218
• UDI-Public: (01)00801902102218(11)230413(17)250328(10)71F23D0412(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 11/07/2023

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: 03/28/2025
• Device Catalogue Number: CS-22703-E
• Device Lot Number: 71F23D0412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 12/20/2023; Not provided
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/22/2023; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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