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

Model Number 3600-100

Device Problems Crack (1135); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report received stated that upon connecting a drain to the patient it was unable to obtain adequate suction.Further review of the drain it was noticed that there was a crack at the top left side of the drain.

Event Description

N/a.

Manufacturer Narrative

Related mdr: 3011175548-2020-01088.Based on the details of the reported complaint the drain had been reported as being cracked on the top left side of the drain and was open to the atmosphere.The drain upon receipt was cracked on the right side of the drain.The crack was rather large and obvious.This is certainly the reason the drain was open to the atmosphere.There was also a line marked on the front cover of the drain at the 200ml fluid level mark indicating that the drain fluid collection was at this point during usage.Damage of this nature is indicative of a drain that either was damaged in transit or was damaged if dropped in the field.Damage of this nature would certainly be discovered during the process of manufacturing, as there are many process steps that are conducted by manufacturing operators.The manufacturing operator just prior to final packaging is required to visibly inspect each drain for particulate, during this inspection damage as seen in the image provided of the actual returned drain would be detectable and rejected at this point in manufacturing.During the process of manufacturing each drain is also 100% pressure tested to ensure there are no leaks in the drain system.Based that the fluid level of 200ml had been achieved indicates that the damage was likely caused by the drain being dropped during use as damage of this nature would also have been very visible to the technician when opening and setting up the drain for use.A review of the device history record did not identify any non-conformances and a review of the incoming inspection records for the purchased drain covers show that they passed the incoming inspection requirements with no non-conformances noted.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 investigation of the physical product atrium medical cannot confirm that the device was shipped in this condition.The crack on the corner of the drain cover appears to have occurred by either shipping damage or damage 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: 10472277
• MDR Text Key: 206111087
• Report Number: 3011175548-2020-01089
• 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,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 68