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

Catalog Number JP-14703-C

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, when blood derivative was injected from the distal lumen, leakage was found near the connection between the hub and the extension line.Therefore, the catheter was removed and replaced with a new one.The extension line was cracked and torn.No patient harm reported.

Event Description

It was reported that, when blood derivative was injected from the distal lumen, leakage was found near the connection between the hub and the extension line.Therefore, the catheter was removed and replaced with a new one.The extension line was cracked and torn.No patient harm reported.

Manufacturer Narrative

(b)(4).The customer returned one 3-lumen cvc for investigation.Evidence of use was observed and the catheter body appeared to be intentionally cut.Visual inspection revealed a hole in the distal extension line directly adjacent to the luer hub.The total length of the catheter body measured to be 270mm which is not within the specification of 307-327mm per catheter product drawing.This indicates that at least 37mm of the catheter were cut and not returned for analysis.The outer diameter of the distal lumen measured to be 2.16mm which is within specifications of 2.13- 2.21mm per extension line extrusion product drawing.The inner diameter of the distal lumen measured to be 1.4732 mm which is within specifications of 1.42-1.50mm 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 saline solution, to establish patency and prime lumen(s)." water leaked out of the hole in distal line.The remaining extension lines flushed as expected.A manual tug test confirmed the medial and proximal extension lines were secure to their respective 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 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 catheter clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the report of an extension line leak was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the distal extension line had a small hole adjacent to 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 will be determined by the capa investigation.Teleflex will continue to monitor and trend complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 30CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 14214894
• MDR Text Key: 290147426
• Report Number: 3006425876-2022-00371
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/04/2022

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: JP-14703-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 05/19/2022
• 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