MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN917805

Device Problem Stretched (1601)

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

Event Date 07/07/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d11: st medium.Qn# (b)(4).

Event Description

It was reported that "patient was in radiology to get ct scan.Contrast fluid was injected and ct scan was done.Next day, the nurse discovered that the lumen which had the contrast fluid, was destroyed.So they put the red cap on it to prevent further use of this destroyed lumen.They replaced the cvc with a new one.They did flush the line prior to use , there is an alarm on the ct-pump so the pressure is max 300 psi and it did not go off." the patient's condition is reported as fine.The cvc had been in place for 7 days in the right internal jugular.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17537693
• MDR Text Key: 321069063
• Report Number: 3006425876-2023-00758
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 07/20/2023

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 Operator: Health Professional
• Device Model Number: IPN917805
• Device Catalogue Number: EU-42854-HPS
• Device Lot Number: 71F23C0701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2022
• 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: CT PUMP, NACL 0.9% INFUSION 3ML/HR PRIOR TO CONTRA