MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS ACCESSORIES - OTHER; BOTTLE, COLLECTION, VACUUM

Model Number 19927

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

It was reported that while administering tpa, the device came apart at connection where luer-lock is connected to tubing.

Manufacturer Narrative

A review of the details of the complaint indicated that while administering tissue plasminogen activator (tpa), the device came apart at connection where luer-lock is connected to tubing.The connector at the end of the tubing (on the left hand side) is a luer lock connector.The patient required a change earlier in the week for the procedure.As the device in question was not returned and the lot number of the device not provided it is difficult to determine the root cause.Two other complaints from the same institution were evaluated.The summary of the other two related complaints were as follows following a full investigation including the testing of 25 additional samples from inventory: ¿upon opening the returned device the luer lock was still inside the tubing as shipped.Upon further inspection there were bodily fluids in the area of the seal that is made when the luer lock is pushed over the connector.To determine the pull out force of the connector from the tubing a 10lb force gauge was obtained.A 3-way stopcock was connected to the force gauge and the luer connector of the returned sample measured.The connector pulled out of the tubing at 5.8 lbs.As the lot number of the connector luer-lock was not provided, a box of 25 new samples were obtained from inventory.All 25 samples were then tested to determine the pull out force of the luer lock connector from the tubing in the same manner as tested above on the returned sample.In all cases the maximum load exceeded the range of the 10 lb force gauge.Based on the results it is clear that the pull out force of the connector from the tubing out of the package exceeds 10 lbs of force.In this regard the technician would have had to generate over 10 lbs of force on the tubing and connector while administering tpa for the connector to pull out of the tubing.A review of the complaint log indicates that there has never been a failure of this nature for this product code going back 5 full years.Based on the sales in the last 3 years for this product code #199927 there has been 21,575 units sold without a complaint due to the connector pulling out of the tubing.¿ conclusion: based on the details provided and the testing results of the associated complaints atrium medical corporation cannot conclude that the luer-lock w/tube was faulty.It is likely that the technician applied far too much force to the connector during use that separated the connector from the tubing.

• Brand Name: DRAINS ACCESSORIES - OTHER
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10037197
• MDR Text Key: 190317748
• Report Number: 3011175548-2020-00650
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19927
• Device Catalogue Number: 19927
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1