MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Model Number IPN030081

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "clogged catheter when inserted".A new device was used.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer report of a blocked catheter could not be confirmed by visual inspection of the customer supplied photo.Additionally, full 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, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300psi) to reduce risk of intraluminal leakage or catheter rupture." 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.

Event Description

It was reported "clogged catheter when inserted".A new device was used.The patient's condition is reported as fine.

Event Description

It was reported "clogged catheter when inserted".A new device was used.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer provided four photos for analysis.The images show the product lidstocks and components included within each kit.The customer also returned multiple components of a cvc kit , including one 2-l pediatric catheter, 5cc syringe, and dilator, for analysis.No definite signs of use were observed.Visual analysis of the catheter revealed no obvious defects or anomalies.The overall length of the catheter measured 5 3/16" which is within the specification limits of 4 13/16" - 5 3/16" per the catheter product drawing.The catheter outer diameter measured 0.05715" which is within the specification limits of 0.054" - 0.058" per the catheter extrusion graphic.The catheter was functionally tested per the instructions per use provided with this kit , which instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s).".Both extension lines were flushed with the returned syringe, and both flushed as intended.No blockages were identified.A manual tug test confirmed that both extension lines were secure within their respective luer hubs.A device history record review was performed and no relevant findings were identified.The ifu informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.Ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture.".The customer report of a blocked catheter was not confirmed through investigation of the returned sample.The catheter passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.Based on the customer report and the sample received, no problem was found.Teleflex will continue to monitor and trend on reports of this nature.Corrected data: section b.4.-date of this report corrected to 30-may-2023.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17198801
• MDR Text Key: 318207307
• Report Number: 9680794-2023-00491
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: 00801902102140
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2023

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 Model Number: IPN030081
• Device Catalogue Number: CS-14402
• Device Lot Number: 14F22M0166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 07/20/2023; 09/15/2023
• Supplement Dates FDA Received: 07/24/2023; 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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; NOT REPORTED
• Patient Age: 3 MO
• Patient Sex: Female
• Patient Weight: 3 KG