MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 2L 5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number CS-14502

Device Problem Product Quality Problem (1506)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: (b)(6) 2023, the doctor found the swg tip rough feel/appearance during used on the patient.The swg tip pierce of blood vessel wall." the patient was reported as "good".Additional information has been requested from the account.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or sheath/dilator assembly as this can lead to vessel perforation, bleeding, or component damage." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: "on (b)(6) 2023, the doctor found the swg tip rough feel/appearance during used on the patient.The swg tip pierce of blood vessel wall." the patient was reported as "good".Additional information has been requested from the account.

• Brand Name: CVC SET: 2L 5 FR X 13 CM
• Type of Device: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18299960
• MDR Text Key: 330140951
• Report Number: 3006425876-2023-01221
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 30801921122939
• UDI-Public: 30801921122939
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CS-14502
• Device Lot Number: 71F20G2829
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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: NOT REPORTED.; NOT REPORTED.