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

Model Number	2002-300
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
Event or Problem Description
Nurse found that there is a 1.7cm break line on the suction control stopcock before reaching the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected d.10 and g.4.
Additional Manufacturer Narrative
Additional information in d.10.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The details provided indicate that the stopcock was cracked on the patient line and was noticed prior to use.Upon inspecting the returned ocean drain the crack in the stopcock was confirmed.There were no other signs of damage to the drain.The body of the drain and the tube set pouch appeared to be in good condition.The crack on the stopcock was only on one side of the stopcock.The length of the crack was approximately 1.5cm in length.There were no other obvious signs of damage.The crack in the stopcock would be an obvious defect for the person handling the subassembly during manufacturing.A review of the device history records was conducted.There were no abnormalities during the build of the product and there were no non conformances during the manufacture of the product.A review of the bill of materials indicates that there were two separate lots of suction line stopcocks used in this build of ocean chest drains.A review of the incoming inspections for both lot numbers was conducted.Both lots were reviewed and there were no non-conformances noted during this inspection.To ensure the returned ocean drain with the cracked stopcock performed properly the drain was prepped per the instructions for use and a vacuum applied of approximately -109 cmh20 with the cracked stopcock in the closed position.No bubbling was seen in the suction control chamber as expected.As the stopcock was slowly opened a gentle bubbling began and increased as the stopcock valve position was increased.This is considered proper operation.Summary/conclusion: the stopcock was able to be adjusted until gentile bubbling in the suction chamber occurred.The stopcock could be opened further to create aggressive bubbling, demonstrating that there was no leak through the crack, or that any leak was not significant enough to affect the use of the chest drain that concluded that the crack in the stopcock was not significant enough to effect the use of the chest drain.

• Brand Name: OCEAN DRAIN
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9432731
• Report Number: 3011175548-2019-01217
• Device Sequence Number: 2654692
• Product Code: KDQ
• UDI-Device Identifier: 00650862100105
• UDI-Public: 00650862100105
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/06/2019

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: 01/25/2021
• Device Model Number: 2002-300
• Device Catalogue Number: 2002-300
• Device Lot Number: 426306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/23/2020; 01/23/2020; 03/06/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 02/20/2020; 02/20/2020; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1