MAUDE Adverse Event Report: COVIDIEN AQUA-SEAL CDU; BOTTLE, COLLECTION, VACUUM

Model Number	8888571299
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the pleurovac does not vacuum/suction.The customer reported patient injury as superior vena cava syndrome.No additional information has been provided at this time.
Additional Manufacturer Narrative
Section e1 was updated with the initial reporter's name, email address and phone number.The following statement was removed from section b5: "the customer reported patient injury as superior vena cava syndrome.No additional information has been provided at this time." "superior vena cava syndrome" was added to section b7 as the initial reporter confirmed that the patient had superior vena cava syndrome prior to use of the pleurovac (chest drainage unit).
Event or Problem Description
The customer reported that the pleurovac does not vacuum/suction.

• Brand Name: AQUA-SEAL CDU
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 9835858
• Report Number: 9611018-2020-00419
• Device Sequence Number: 2830068
• Product Code: KDQ
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/15/2020

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: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 19B054FHX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1