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

Model Number	2002-000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
Event or Problem Description
Report received stated that damage was noticed on the outer carton of drain in stock.Drain was removed and replaced with new stock.
Additional Manufacturer Narrative
The manufacturing lot records were reviewed and found to be complete and has met all finished good specifications.Upon inspection the outer packaging materials were in good condition with no signs of the sterile barrier being breached.The sealed pouch was then opened and the blue csr wrap removed from the drain.Upon a full review of the physical drain no damage was noted.A packaging ship test was conducted to ensure the integrity of the product in its current packaging configuration.The results of this testing showed that the device met all requirements of iso 11607-1 (part 1) for package performance.Summary/conclusion - based on the results of the investigation this drain was not damaged.

• Brand Name: OCEAN DRAINS
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8521192
• Report Number: 3011175548-2019-00402
• Device Sequence Number: 19300351
• Product Code: KDQ
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2021
• Device Model Number: 2002-000
• Device Catalogue Number: 2002-000
• Device Lot Number: 425667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1