MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "the junction site between extension line and luer-hub (brown head) had a breach caused leaking." no patient harm reported.The device was removed and replaced.The patient's condition is reported as fine.

Event Description

The complaint is reported as: "the junction site between extension line and luer-hub (brown head) had a breach caused leaking." no patient harm reported.The device was removed and replaced.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(6).The customer returned one 3-l catheter for evaluation.Visual inspection of the catheter revealed there was a large hole in the distal extension line adjacent to the luer hub.The total length of the catheter measured 220 mm which is within specifications of 207-227 mm per catheter graphic drawing.The outer diameter of the distal extension line measured 2.179 mm which is within specifications of 2.130-2.210 mm per distal extrusion graphic.The inner diameter of the distal extension line measured 1.4732 mm which is within specifications of 1.42-1.50 mm per distal extrusion graphic.This indicates that the wall thickness measured within specifications.The returned sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "flush lumen(s) to completely clear blood from catheter." when the distal line was flushed, water leaked from the hole adjacent to the luer hub.No leaks were observed when the proximal and medial lumens were flushed.A manual tug test confirmed that all three extension lines were secure within 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 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." the customer report of an extension line leak was confirmed by functional and visual inspection of the returned sample.The distal extension line contained a hole adjacent to the luer.A device history record review was performed based on sales history, and no relevant findings were identified.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 reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 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: 12610059
• MDR Text Key: 276605914
• Report Number: 3006425876-2021-00955
• 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: 09/23/2021

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 Catalogue Number: CS-25703-E
• Device Lot Number: UNKNOWN
• 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: 09/23/2021
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/12/2021
• 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: NONE REPORTED.; NONE REPORTED.