MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. 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 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "the luer-hub (brown head) on patient's right neck suddenly had a breach and broken to cause leaking while rolling patient over." no patient harm or injury.The device was replaced.

Manufacturer Narrative

(b)(4).The customer returned one 3-lumen cvc for investigation.Visual inspection revealed the distal extension line was separated directly adjacent to the luer hub.Remains of the extension line were found inside the luer hub.The catheter body appeared intentionally trimmed.The separated portion was not returned.The total length of the catheter body measured to be 291 mm which indicates that at least 19 mm of the catheter body was not returned per product drawing.The outer diameter of the distal lumen measured to be 2.17 mm which is within specifications of 2.13-2.21 mm per product drawing.The inner diameter of the distal lumen measured to be 1.47 mm which is within specifications of 1.42-1.50 mm per product drawing.This indicates that the wall thickness measured within specifications.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the proximal and medial lumens were flushed using a water-filled lab inventory syringe.Biological material exited both lumens.After the build-up of biological was removed , both lumens flushed as expected.A manual tug test confirmed the proximal and medial extension lines were fully secured within the luer hubs.A device history record review was performed with no relevant findings.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.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.Open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." 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.It was noted that remains of the extension line were found within the luer hub.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.The root cause of this issue has not yet been determined.Teleflex will continue to monitor and trend complaints of this nature.

Event Description

The complaint is reported as: "the luer-hub (brown head) on patient's right neck suddenly had a breach and broken to cause leaking while rolling patient over." no patient harm or injury.The device was replaced.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 12660505
• MDR Text Key: 277256890
• Report Number: 3006425876-2021-00970
• 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: 09/29/2021

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 Expiration Date: 12/01/2022
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F21A2046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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