MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OCEAN BRU; APPARATUS, AUTOTRANSFUSION

Model Number	2050-000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Report received stated that the tethered stopper (vent plug) on top of the drain was missing.
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Additional Manufacturer Narrative
The customer reported that the "lid of the chamber" was missing from a 2050-000 drain.Pictures were provided and the drain was returned without any of its original packaging.Upon investigation of the returned drain, it appears that the drain was being set up and water was added to the water seal chamber, but there is no sign the drain was used on a patient.The tethered stopper is missing from the drain, confirming the complaint.There are no signs of damage to the drain or that the stopper's tether broke.The device is missing the stopper and so is not conforming to its specifications.The device nonconformity is confirmed.A dhr review was completed which found no anomalies in the manufacturing process.The quantities of stoppers issued to the manufacturing lot of drains indicated that all stoppers were unaccounted for.The ifu provides adequate instructions for the setup of the device and instructs the user not to use the device if it is damaged.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found no related complaints.A recurring lot number report was completed which found no related complaints.A review of cars/capas found none related to this complaint.A ncr review found none related to this complaint.A review of scars found none related to this complaint.Both the complaint and the device nonconformity were confirmed in the device evaluation.The dhr review did not identify any anomalies in the manufacturing of lot 471086.The component quantities and scrap quantities indicated that all components were accounted for.No evidence has been identified to suggest the drain left getinge without the tethered stopper.It is not definitively known how this nonconformity occurred, so the root-cause is impossible to define.
Event or Problem Description
N/a.

• Brand Name: DRAINS OCEAN BRU
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 13934437
• Report Number: 3011175548-2022-00112
• Device Sequence Number: 17326229
• Product Code: CAC
• UDI-Device Identifier: 00650862103014
• UDI-Public: 00650862103014
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2023
• 2 Devices were Involved in the Event: 1 2

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: 04/14/2024
• Device Model Number: 2050-000
• Device Catalogue Number: 2050-000
• Device Lot Number: 471086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 01/05/2023; 02/02/2023
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 01/06/2023; 02/06/2023
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown