MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-24703-E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

It was reported "the luer-hub(brown) was leaking".No patient harm was reported.The catheter was replaced.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one 3-l catheter for analysis.Signs of use were observed on the catheter body and extension lines.Visual inspection of the catheter revealed the distal extension line separated from the luer hub.The inside of the luer hub appeared deformed and lumpy.Remains of the extension line molding were visible deep inside the luer hub.The extension line was rough and jagged at the point of separation.The catheter length measured 324mm, which is within the specifications of 310-330mm per product drawing.The distal extension line outer diameter measured 2.21mm, which is within the specifications of 2.13mm-2.21mm per product drawing.The distal extension line inner diameter measured 1.4732mm, which is within the specifications of 1.42-1.50mm per product drawing.Functional inspection of the catheter was performed per the product ifu which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the proximal and medial extension lines were flushed using a lab inventory 10ml syringe.Both extension lines flushed normally.No leaks or blockages were observed.Functional inspection of the distal extension line could not be performed due to the damage.A manual tug test confirmed the medial and proximal extension lines were secured to their respective luer hubs.Manufacturing was contacted as part of this complaint investigation.They performed a sample investigation and indicated the following findings: the extension line extrusion was properly inserted inside the hub, indicating no operator error.The extrusion looks to be corroded or lifted from the hub by an aggressive solvent or extensive mechanical stress.They indicate that the appearance of this separation is not consistent with previously observed manufacturing defects.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 this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.".The report of an extension line/luer hub separation was confirmed through complaint investigation.Visual analysis revealed that the distal extension line had separated adjacent to the luer hub.The luer hub was severely deformed and the extrusion inside the hub appeared to have been separated from the hub after separation.The catheter met all relevant dimensional requirements, and a device history record review based on sales history was performed with no relevant findings.Manufacturing performed a sample investigation and indicated that the appearance of this defect is not consistent with the scope of a previously opened capa.Based on these circumstances, the condition of the sample received, and the comments from manufacturing , unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend complaints of this nature.Corrected data: section d.1.-brand name corrected to arrow cvc set: 3-lumen 7 fr x 30 cm section d.4.-catalog# corrected to cs-24703-e.Section d.4.-lot# is unknown.

Event Description

It was reported "the luer-hub(brown) was leaking".No patient harm was reported.The catheter was replaced.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 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: 15956303
• MDR Text Key: 307794622
• Report Number: 3006425876-2022-01060
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/16/2023
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F21M0351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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