MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Received a report that the drain came out of the package with a defective suction nozzle.

Manufacturer Narrative

The sample has been received and a follow up report will be submitted upon the completion of the investigation.

Manufacturer Narrative

The oasis chest drain was returned and removed from the large bio-hazard bag that the drain was packaged in.Upon opening the bag it was clear that the blue suction nozzle had been struck at some point after being shipped to the institution.Damage of this nature would have very easily been recognized by the manufacturing operator.The drain otherwise was in good condition.There were no other signs of damage.The box that the drain was shipped in from the factory was not returned.During the process of manufacture the operator conducts a 100% visual and tactile inspection of the welded vacuum nozzle to ensure it was properly welded in place.If the nozzle would have been damaged it would have been noticed during the inspection process.A review of the device history records and incoming inspection records of the oasis chest drain were conducted to ensure they met all quality and performance requirements and that there were no non-conformances during the manufacturing build.Summary/conclusion - based on the investigation atrium medical corporation cannot conclude that the nozzle was damaged at the site of manufacture.It is likely the nozzle was damaged either in transit or after it was removed from the package at the institution.

• Brand Name: DRAINS OASIS SINGLE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9672224
• MDR Text Key: 181978409
• Report Number: 3011175548-2020-00250
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2022
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 443360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1