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

Model Number IPN915752

Device Problem Obstruction of Flow (2423)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the head of the operating theatre reported that the white lumen of the cvc could not be flushed." the cvc was removed and replaced with a new one.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).The customer returned one, 3-lumen cvc for analysis.Signs-of-use were observed inside the proximal extension line.After failing functional testing, a blockage was encountered inside the proximal extension line.A long pin gage was inserted through the line.Large quantities of congealed biological material were observed exiting the proximal skive hole.Once removed, the proximal line was able to flush as intended.The catheter body length from the juncture hub to the distal tip measured 316mm , which is within the specification limits of 307mm-327mm per the catheter product drawing.The catheter body outer diameter measured 2.46mm, which is within the specification limits of 2.39mm-2.49mm per the catheter extrusion product drawing.A lab inventory syringe filled with water was attached to all three extension lines and flushed.The distal and medial lines flushed as intended.When flushing the proximal line, a total blockage was encountered.A long pin gage was passed through the proximal line.Large quantities of congealed biological material exited the proximal skive hole.Once removed, the proximal line flushed as intended.Performed per ifu statement, "flush lumen(s) to completely clear blood from catheter".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture".The ifu also states, "flush lumen(s) to completely clear blood from catheter".The report of a blocked extension line was confirmed through complaint investigation.Visual and functional analysis revealed that the proximal extension line was blocked due to a build-up of congealed biological material.Once removed, the line flushed as intended.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "the head of the operating theatre reported that the white lumen of the cvc could not be flushed." the cvc was removed and replaced with a new one.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 30CM
• 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: 19029167
• MDR Text Key: 339229542
• Report Number: 3006425876-2024-00346
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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: IPN915752
• Device Catalogue Number: DE-14703-CB
• Device Lot Number: 71F23J0127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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.