MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OCEAN; DRAIN, TOTAL RECOVERY W/AC, S

Model Number	2050-000
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
Report received stated that a covidien 24fr chest tube could not be attached to the connector of an ocean drain.Another drain was opened and they were able to attach the chest tube.
Additional Manufacturer Narrative
The product was not returned for analysis.All adult drains have the same connector attached to the patient tube.There is no reason why one drain would fit and another would not.None of the subject patient tubes or finished drains are in stock, so a representative sample could not be pulled for analysis.The only tube set that would have a different connector is used on the pedi drains and the tubing size difference would preclude attaching a pedi tube set to a standard drain, as the drain ports sizes are different - the larger port on the standard drain would not accept the smaller tube diameter of the pedi tube set.Engineering summary/conclusion: no root cause could be identified.Unless the connector was changed by the user there is no reason why the original unit would not have been compatible with the catheter.

• Brand Name: OCEAN
• Common Device Name: DRAIN, TOTAL RECOVERY W/AC, S
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 6119506
• Report Number: 1219977-2016-00237
• Device Sequence Number: 1075888
• Product Code: KDQ
• UDI-Device Identifier: 00650862103014
• UDI-Public: 00650862103014
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 07/27/2019
• Device Model Number: 2050-000
• Device Catalogue Number: 2050-000
• Device Lot Number: 240161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 12/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 89