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

Model Number IPN030789

Device Problem Obstruction of Flow (2423)

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

Event Date 12/17/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

"during functional check-up of the device, the distal extension line where the parenteral nutrition was administered is completed obstructed and it is impossible to flush." additional information reports, the patient had undergone embolization.The patient's current condition is reported as "fine".Additional mdr number 3006425876-2024-00153.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.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

"during functional check-up of the device, the distal extension line where the parenteral nutrition was administered is completed obstructed and it is impossible to flush." additional information reports, the patient had undergone embolization.The patient's current condition is reported as "fine".Additional mdr number 3006425876-2024-00153.

• Brand Name: CVC SET: 2-LUMEN 7 FR X 20 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18652125
• MDR Text Key: 336064983
• Report Number: 3006425876-2024-00154
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN030789
• Device Catalogue Number: CS-16702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; NONE REPORTED
• Patient Sex: Female