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

Catalog Number	CV-22703-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the physician, while preparing the cvc set before injecting it into the patient, discovered that the wire in the package was kinked." associated complaints: (b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the physician, while preparing the cvc set before injecting it into the patient, discovered that the wire in the package was kinked." associated complaints: 3006425876-2024-00935, 3006425876-2024-00934, 3006425876-2024-00933 and 3006425876-2024-00930.
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of a kinked guide wire was able to be confirmed by the photos as they revealed kinking of the guide wire when assembled within the advancer assembly in the window of the thumb guide.Neither the straightener tubing nor the end cap were present in the photo.The product lidstock was additionally pictured.Without the sample returned for analysis , a complete visual inspection could not be performed.A device history record review was performed, and no relevant findings were identified.The customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photos.The image shows a guide wire within the advancer tube with several kinks, however, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 16CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 20333058
• Report Number: 3006425876-2024-00935
• Device Sequence Number: 8003702
• Product Code: FOZ
• UDI-Device Identifier: 10801902029338
• UDI-Public: (01)10801902029338(11)230920(17)250823(10)71F23J0779(21)
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2025
• Device Catalogue Number: CV-22703-E
• Device Lot Number: 71F23J0779
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2023
• 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
• Patient Sex: Unknown