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

Model Number 3600-100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up will be submitted upon completion of the investigation.

Event Description

Report received stated that the drain was leaking patient fluid out of the bottom of the drain.

Manufacturer Narrative

Related mdr: 3011175548-2020-01089.Based on the details of the complaint provided the drain in question was leaking from the bottom of the drain.The drain in question was not returned and images not provided for evaluation and as such cannot confirm the complaint.During the process of manufacturing each drain is 100% pressure tested to ensure there are no leaks in the drain system following the manufacturing procedure.A review of the device history record did not identify any non-conformances and a review of the incoming inspection of the drain cover part number showed the product passed all incoming inspection requirements without any non-conformances.The other associated drain complaint was returned and evaluated.The returned exhibited a crack and was most likely either caused by shipping damage or was dropped during use.As the drain in this complaint is from the same institution and same product lot number the leak in this drain complaint is also likely caused by shipping or handling damage after leaving the manufacturing site.Without the drain or images an assessment of the damage cannot be conducted.All drains are bulk packaged 6 to a box and it is likely that the box had been damaged in transit.The instructions for use (ifu) states in the precautions section the following: "replace chest drain if damaged or when collection volume meets or exceeds maximum capacity.Do not use if device or package is damaged." based on the complaint details and device history records review, it cannot be confirmed that the device was shipped in this condition.The leak of the drain appears to have occurred by either shipping damage or damage at the institution.H3 other text : not available for return.

• 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: 10472268
• MDR Text Key: 206128239
• Report Number: 3011175548-2020-01088
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 454831
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 68