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

Model Number	2020-000
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
Event or Problem Description
It was reported that on removal of the drain from the packaging the patient tubing was noted to be kinked.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A review of the images provided show that there is a kink in the tubing on the patient line as described in the complaint details.The kink in the tubing although undesirable cosmetically still meets the flow requirements as stated in the product performance specifications.A device history record review was performed and the lot of drains met the quality and performance requirements prior to release in an effort to enhance the clinician experience and reduce waste, atrium medical corporation introduced enhancements to the atrium chest drain family that simplify packaging and routine set-up of atrium chest drains.These enhancements factored-in clinician workflow exhibit multiple benefits, such as reducing costs associated with medical waste in the hospital as well as reducing manufacturing carbon footprint.As part of this initiative, the wall thickness of the patient tube set was modified from.094+/-.012 inches for the 3/8 inch tubing and.094 +/- 0.16 inches on the 1/4 in tubing to a minimum specification of.088 +/-.006 inches.The dimensional changes were still within the original product requirements.Letters of these changes were sent out to the customers and distributers in february 2019.In an effort to ensure the product was still performing properly, a planned engineering study that had been conducted prior to this complaint investigation in march 2020 (dd019971 drains kinking evaluation) was conducted using 59 samples from inventory that were sterilized 3x times.This study was created to ensure the threshold for airflow going through the tube set did not drop below the required 7.5slpm after applying a 150 gram weight to the tube set.The result was that the lowest value recorded was 24.85slpm.This is much higher than the threshold value.Although the kink in the tubing is undesirable the flow is very much still within the 7.5 slpm requirements.Based on the results of the investigation the kink in the tubing still meets the product requirement for flow as determined in the planned engineering study.Due to the feedback from the customers, a design control quality plan has been initiated to reverse the change that called for the wall thickness reduction.
Additional Manufacturer Narrative
Additional information: d4, h4 and h6.
Event or Problem Description
N/a.

• 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: 10283215
• Report Number: 3011175548-2020-00932
• Device Sequence Number: 14166552
• Product Code: KDQ
• UDI-Device Identifier: 00650862102017
• UDI-Public: 00650862102017
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2020

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: 02/05/2023
• Device Model Number: 2020-000
• Device Catalogue Number: 2020-000
• Device Lot Number: 454828
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/19/2020; 10/06/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/27/2020; 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1