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

Model Number 3600-100

Device Problems Suction Problem (2170); Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 10/03/2017

Event Type  malfunction  

Event Description

Staff member was changing out chest tube (atrium oasis dry suction water seal chest drain) because the old one was full.When she went to connect the suction tubing from the wall suction to the blue suction spout on the device she noticed that it was not creating a seal (the suction would not work).She said you could pull the blue spout out of the device because it wasn't properly glued or seated in.Manufacturer response for water seal chest drain, oasis (per site reporter): they sent me shipping material.

• Brand Name: OASIS
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• MDR Report Key: 6950789
• MDR Text Key: 89365375
• Report Number: 6950789
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/01/2020
• Device Model Number: 3600-100
• Device Lot Number: 419857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO