MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC AQUA-SEAL; BOTTLE, COLLECTION, VACUUM

Model Number	8888571299
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 health effect - clinical code - appropriate term / code not available - worsening of preexisting conditions.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported an infant patient who had pneumothorax where a drain was inserted but air reaccumulated into the chest.The only way to resolve this was to manually suction with a syringe.The customer assumed a bronchopulmonary fistula was present leading to a continuous air leak but due to the unique condition that the patient had, the patient had their chest opened as part of their management.At operation, the patient did not have a pleural leak identified and yet air could be freely aspirated from the chest.The customer stated that they are concerned that there is a problem with the underwater seal unit as it was replaced by a different unit from another manufacturer and the air in the chest resolved both clinically and on x-ray.The patient and drain were transported to another hospital to facilitate ecmo.Additional information received on (b)(6) 2025 stated that the patient's age is unknown but under 28 days old.The patient had a congenital heart defect.The opening of the chest was exploratory surgery based on the assumption that there was a bronchopulmonary fistula.The patient was transferred to an ecmo site due to the unresolving pneumothorax.The patient recovered well after surgery.
Additional Manufacturer Narrative
The device history record review could not be performed since no lot number was provided.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to determine the root cause.We will continue to monitor reports and take actions as applicable.
Additional Manufacturer Narrative
H6 evaluation codes: investigation finding code and investigation conclusion code has been corrected.

• Brand Name: AQUA-SEAL
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22898727
• Report Number: 1423537-2025-00346
• Device Sequence Number: 5986576
• Product Code: KDQ
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/11/2025; 09/22/2025
• 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