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

Model Number	8888571299
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that it was necessary to change the adult thoracic drainage system for one of the same capacity because the columns were mixed without the equipment falling.It caught their attention to see that the water from the water seal that is colored blue was in the last column of the drain.There was no patient injury.The device was being operated in the hospital at the time of this event.There was no recidivism.There is no photographic or physical evidence of the medical device.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.All acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.During the manufacturing process on aqua seal vessels, they are all 100% leak tested and 100% functionally tested as part of the process.Also, independent sampling is complete by quality assurance to confirm units are functioning correctly.A sample was not received for the investigation.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to confirm the reported condition, determine the root cause(s), or implement any corrective action(s).If a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.This complaint will be used for tracking and trending purposes.

• Brand Name: AQUA-SEAL CDU
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14372294
• Report Number: 9611018-2022-00559
• Device Sequence Number: 1983598
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 21E178FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown