MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRAIN; DRAIN, DRY SINGLE W/AC

Model Number 3600-100

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated that the customer found two cuts in the inner packaging of the chest drain.

Manufacturer Narrative

The returned device was opened and inspected for damage.There was no visible damage noted of the tyvek/nylon pouch.The drain was removed from the pouch and the csr wrap was removed from the drain.The csr wrap had an area marked with a circle indicating the slit in the wrap.Both wraps were noted to have the same slit in the same area.During the inspection the wedge tray that the drain is placed into was noted to be crushed on one corner.The slits in the wrap correspond to the opposite corner of the wedged tray.Oasis drains are packaged following manufacturing procedures and each piece of csr wrap is inspected for damage including, but not limited to, tears and pinholes.A device history record review was performed and the drain lot was found to have met all specifications.The cause of the slits in the csr wrap appear to be attributed to damage during shipping or handling of the unit.The handling and distribution simulation testing, which was conducted for this product line, is intended to subject products to conditions they may typically encounter in their distribution cycle.The testing is not inclusive of every event that may occur to a product during distribution.Clinical evaluation: a package that is damaged would be noticed prior to admission to a sterile field.

• Brand Name: OASIS DRAIN
• Type of Device: DRAIN, DRY SINGLE W/AC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6619979
• MDR Text Key: 77297082
• Report Number: 1219977-2017-00085
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

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
• Device Operator: Other Health Care Professional
• Device Expiration Date: 01/04/2020
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 246605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: 08/02/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1