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

Model Number	8888571299
Medical Device Problem Codes	Decrease in Suction (1146); Leak/Splash (1354)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the pleurovac cap does not seal, causing loss of negative pressure in the right lung tube, leading to decreased drainage of the hemothorax causing a residual right pneumothorax of the patient.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot 20h055fhx.The complaint details indicated that the physical sample is not available to be returned for evaluation.Instead, a video was provided for review.Upon review of the video, the cap does not seem to have been closed fully by the personnel closing it.However, the manufacturing site was not able to confirm if there is a failure on the cap as a physical sample was not returned.Without the physical sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to confirm the reported issue, determine the root cause(s) of the reported condition or implement any corrective action(s).If a sample is returned at a later date, this complaint will be reopened, and the investigation will be updated to reflect our findings.Please note that the instructions for use (ifu) state in section 2 ¿close suction control cap using the tethered cap.Make sure cap ¿snaps¿ tightly into place¿.During the investigation, the manufacturing site took a device from the manufacturing line, closing the cap tightly and the snap can be heard.Based on all available information, the manufacturing site was unable to confirm the complaint.At this time, there is not enough information, and a corrective and preventive action (capa) will not be initiated.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.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 st; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14171339
• Report Number: 9611018-2022-00555
• Device Sequence Number: 5024593
• 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): 06/03/2022

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?: Yes
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 20H055FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female