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

Model Number	8888571299
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device may 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
Customer reports: the sealing chamber is being sucked to the wall after 30 minutes of being connected to patient.The unit/s worked properly for 30 minutes but after that the suction started to decrease and the blue sealing liquid was sucked against the wall.
Additional Manufacturer Narrative
The device history record (dhr) review for lot 19j112fhx showed that all acceptance criteria.Inspections per established sampling levels were within acceptable limits during the production process.A diagram and a video of the reported issue were received and reviewed.Upon inspection, the reported issue could not be confirmed.One (1) used sample was returned to the manufacturing site in relation to this report.Unfortunately, the set is contaminated with a dried red matter that is unfamiliar to the site, therefore the sample could not be tested.The return of the sample has no effect on the investigation as sample could not be tested and complaint cannot be confirmed.A root cause could not be determined, and a corrective action is not necessary at this time.This complaint will be used for tracking and trending purposes.

• 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: 10757177
• Report Number: 9611018-2020-00460
• Device Sequence Number: 1191675
• Product Code: KDQ
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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): 05/04/2021

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: 19J112FHX
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 05/04/2021
• Patient Sequence Number: 1