MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number IPN918647

Device Problem Obstruction of Flow (2423)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Associated mdr#s: 3006425876-2023-00362.

Event Description

It was reported after insertion, while the lines were checked, the physician observed there was no backflow on the distal line.A new catheter was inserted and the same issue occurred with the second catheter.It was decided to leave the second catheter inserted in the patient.No patient harm or consequence reported.

Event Description

It was reported after insertion, while the lines were checked, the physician observed there was no backflow on the distal line.A new catheter was inserted and the same issue occurred with the second catheter.It was decided to leave the second catheter inserted in the patient.No patient harm or consequence reported.

Manufacturer Narrative

(b)(4).Associated mdr#s: 3006425876-2023-00362.The customer returned one 3-l cvc for analysis.Significant signs of use in the form of biomaterial were observed on the catheter body and inside the extension lines.Initial visual inspection of the catheter revealed no obvious defects or anomalies.The catheter body length from the juncture hub to the distal end measured 214mm , which is within the specifications of 208.5-225mm per product drawing.Functional inspection of the catheter was performed per the instructions for use (ifu) provided with the kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the medial and proximal extension lines flushed as expected, with no leaks or blockages observed.While flushing the distal lumen, it was noted that water would not exit the distal end of the catheter despite significant pressure being applied, indicating a blockage.A long pin gauge was inserted through the catheter to determine the location and source of the blockage.Significant amounts of biomaterial were removed from the distal lumen of the catheter.Once the biomaterial was removed, the functional test was repeated, and water was observed exiting the distal end as intended.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the 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 300 psi) to reduce risk of intraluminal leakage or catheter rupture." the customer report of a blocked extension line was confirmed through complaint investigation of the returned sample.Functional inspection revealed the distal lumen was blocked due to an excess of biomaterial within the lumen.The returned catheter met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• 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: 16779658
• MDR Text Key: 313722829
• Report Number: 3006425876-2023-00363
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/27/2023

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: IPN918647
• Device Catalogue Number: CS-15853
• Device Lot Number: 71F22E7679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• 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.