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

Model Number 19927

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

Event Description

Nighttime bedside respiratory therapist performing standard tissue plasminogen activator administration as per protocol.While flushing the tissue plasminogen activator, the luer-lock connector became disconnected at the flexible tubing, leaving system open to patient.Frontline staff re-inserted the connector, and taped to secure.Daytime respiratory therapist, switched out device.

Event Description

N/a.

Manufacturer Narrative

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 5.8lbs.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 the returned sample was tested.In all cases the maximum load exceeded the range of the 10lb force gauge.Based on the results it is clear that the pull out force of the connector from the tubing out of the package exceeds10lbs of force.In this regard the technician would have had to generate over 10lbs of force on the tubing and connector while administering tissue plasminogen activator (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 there has been 21,575 units sold without a complaint due to the connector pulling out of the tubing.Summary/conclusion - based on the details provided and the evaluation of the physical product 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.Even after the connector was separated from the tubing and reinserted the force to remove the connector exceeded 5lbs.

Event Description

N/a.

• Brand Name: DRAINS ACCESSORIES
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9901127
• MDR Text Key: 186269731
• Report Number: 3011175548-2020-00483
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 19927
• Device Catalogue Number: 19927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention