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

Model Number	3620-100
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Especially for the dual oasis chest drains, they are kinked from the beginning when opened from the package.Silicone is not returning into its original shape so some customers complain saying it does not drain efficiently.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Related mdr's: 3011175548-2022-00191, 3011175548-2022-00200, 3011175548-2022-00199, 3011175548-2022-00201, 3011175548-2022-00202, 3011175548-2022-00203, 3011175548-2022-00204, 3011175548-2022-00213, 3011175548-2022-00205, 3011175548-2022-00206, 3011175548-2022-00208, 3011175548-2022-00209, 3011175548-2022-00212, 3011175548-2022-00210, 3011175548-2022-00207.Sixteen (16) complaints were received, reporting that upon opening oasis dual drains it was discovered that the patient tubes were kinked.The included complaints are (b)(4).Kinked tubing is a known issue to occur with drains manufactured between feb 09, 2019 and october 29, 2021, as identified in capa 439435.The root cause for this issue was determined in capa 439435 to be design control during the redesign of the patient tube.The wall thickness of the patient tube was decreased, which led to an increase in complaints about kinked tubes.Capa 439435 reverted that change, returning the tubes to their previous wall thickness and also adding an end cap to the tubes to help protect them from damage.No confirmed complaints of this issue have been identified for any devices manufactured after capa 439435 was implemented on oct 29, 2021.The lot numbers of the 16 complaints from korea were not provided, so their dhrs could not be reviewed.However, shipping records to the korean distributor revealed that from january 2021 to the present, all but one shipment was from the prior tubing design, prone to the kinking defect observed.These complaints are most likely due to the same root cause as determined in capa 439435.As no devices were returned and no lot numbers were provided, there is no evidence to suggest a different root-cause.One of the complaints was received with a picture of the kinked tube, confirming the complaint for at least one of the drains.A review of the labeling was performed and concluded that there are appropriate precautions in place to handle this issue.The ifu instructs the user not to use a device if it is discovered that the device is damaged.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.H3 other text : not available for return.

• Brand Name: DRAINS OASIS DOUBLE
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• 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: 15100017
• Report Number: 3011175548-2022-00211
• Device Sequence Number: 5438047
• Product Code: KDQ
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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 Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown