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

Model Number 8888571299

Device Problems Decrease in Suction (1146); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported an issue in the sealing cap resulting in the loss of negative pressure causing loss of drainage of the patient's left pleural effusion.

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, 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
• Type of Device: 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: 14171665
• MDR Text Key: 290158871
• Report Number: 9611018-2022-00556
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

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: 20H055FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 06/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Male