MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-27702-E

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection r revealed a slight bend towards the distal end.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported "during the procedure according to ifu, the md found the guide wire to be faulty.So the md opend up the new kit to finish the procedure." no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".The returned device was found to be kinked.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: 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: 19200510
• MDR Text Key: 341357319
• Report Number: 3006425876-2024-00459
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102362
• UDI-Public: 00801902102362
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F22D1272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED