MAUDE Adverse Event Report: COVIDIEN S.S. DUAL DRAIN CDU; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888571513
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer stated device is connected to drains with suction at -20 mh2o.There was presence of air bubbles in the blue compartment which was not allowing the suction to be adjusted.When changing the drainage pack, the drains were clamped and there was no change after removing the clamps.
Additional Manufacturer Narrative
A device history record of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One (1) opened sentinel seal cdu dual drain chest unit was returned for evaluation as part of the customer complaint investigation.Based on a visual inspection of the returned device, no immediate flaws were identified.Functional testing was then completed on the complaint unit in line with the requirements of the sentinel seal / sentinel seal dual c.D.U function test.The analysis included testing for a leakage on many of the components of the cdu including the fill spout pressure relief valve, seal chamber and occlusions.All acceptance criteria for the outlined tests met the product specifications for the returned unit.The unit performed as required.As a result, the customer complaint cannot be confirmed on the sentinel seal cdu dual drain chest unit.A risk assessment was deemed not required as the sample passed all testing and the investigation did not confirm that the reported issue.

• Brand Name: S.S. DUAL DRAIN CDU
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 10341360
• Report Number: 9611018-2020-00430
• Device Sequence Number: 2979176
• Product Code: GCX
• UDI-Device Identifier: 30884521073269
• UDI-Public: 30884521073269
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: No Information
• Device Model Number: 8888571513
• Device Catalogue Number: 8888571513
• Device Lot Number: 19H079FHX
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 10/05/2020
• Patient Sequence Number: 1