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

Catalog Number CS-24402

Device Problem Stretched (1601)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported during the procedure, the physician found the distal line is deformed.A new kit was opened to finish the procedure.There was no harm to the patient.The patient's condition is reported as "fine.".

Event Description

It was reported during the procedure, the physician found the distal line is deformed.A new kit was opened to finish the procedure.There was no harm to the patient.The patient's condition is reported as "fine".

Manufacturer Narrative

(b)(4).The customer returned one 2-l cvc for analysis.Signs of use in the form of biological material was observed on the catheter body and inside the extension lines.The catheter appeared intentionally cut.Visual analysis revealed that the distal extension line was stretched/ballooned.The stretching started adjacent to the distal luer hub.The appearance of the damage is consistent with unintentional over pressurization of the extension line during use.The stretching on the distal extension line measured 1mm-9mm from the distal luer hub.The catheter length from the juncture hub to the severed end measured 2 7/8", which is not within the specifications of 4 13/16"-5 3/16" per product drawing.This indicates that at least 1.9375" of the catheter were severed and not returned for analysis.The distal extension line outer diameter in an area not affected by stretching measured 0.08558", which is within the specifications of 0.084"-0.088" per product drawing.The distal extension line inner diameter measured 0.057", which is within the specifications of 0.055"-0.059" per product drawing.A lab inventory syringe filled with water was attached to the distal extension and flushed.Water was observed exiting the distal end as intended.No leaks or blockages were observed.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." no obstructions were observed when flushing the proximal extension line.A manual tug test confirmed both extension lines were fully secured onto their respective luer hubs.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 instructions for use (ifu) provided with the kit informs the user, "using catheters not indicated for pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury." and also cautions the user "warning: open slide clamp prior to infusion through lumen to reduce risk ofdamage to extension line from excessive pressure.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 report of a stretched/ballooned extension line was confirmed through complaint investigation.Visual analysis revealed that the distal extension line was stretched/ballooned.The catheter flushed as expected, the catheter met all relevant dimensional requirements, and a device history record review was performed based on a potential lot with no relevant findings to suggest a manufacturing related cause.Based on the customer report and the appearance of the damage to the catheter, unintentional use error (overpressure) likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16311043
• MDR Text Key: 308977123
• Report Number: 3006425876-2023-00123
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K900263
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-24402
• Device Lot Number: 14F22K0196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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: NOT REPORTED; NOT REPORTED