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

Catalog Number CS-22854-E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported there was a leak on one of the extension lines near the hub.No patient harm was reported.The catheter was changed.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one, 4-lumen cvc for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed a small hole on the distal extension line directly adjacent to the juncture hub.Microscopic examination confirmed the damage and revealed that the edges were angled and straight/uniform, which is damage consistent with contact with a sharp instrument (i.E.Scalpel, scissors).No other defects or anomalies were observed.The catheter body length measured 170mm, which is within the specification limits of 157mm-177mm per the catheter product drawing.The distal extension line outer diameter measured 2.16mm, which is within the specification limits of 2.13mm-2.21mm per the distal extension line extrusion product drawing.The distal extension line inner diameter measured 1.4478mm, which is within the specification limits of 1.420mm-1.500mm per the distal extension line extrusion product drawing.A lab inventory syringe filled with water was attached to all four extension lines and flushed.When flushing the distal extension line, water was observed leaking out of the hole.No defects or anomalies were observed when flushing the medial 1, medial 2, or proximal extension lines.Performed per ifu statement, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed".The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The report of a leaking extension line was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the distal line contained a hole directly adjacent to the juncture hub.The appearance of the damage is consistent with contact with a sharp instrument (i.E.Scalpel, scissors).Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported there was a leak on one of the extension lines near the hub.No patient harm was reported.The catheter was changed.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 16398120
• MDR Text Key: 309952968
• Report Number: 9680794-2023-00097
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K962577
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-22854-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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