MAUDE Adverse Event Report: CARDINAL HEALTH ARGYLE ALTITUDE DRY SUCT C D U; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	8888571370
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the patient arrived to the cicu following cardiac surgery.When cardiac drains were attached to the appropriate suction, it did not work effectively.The green suction / patient vacuum indicator did not appear as it should on the altitude drain.Wall suction was checked and it was working adequately therefore the issue was with the altitude cdu drainage bottle.There has been 4 similar incidents (exact number unknown) in the recent past regarding the same issue.Per additional information received, the bedside nurse escalated the issue with not being able to see there was suction being applied.After investigating and checking the wall suction was working, the decision was made to change the drainage bottle to ensure patient safety.This is an unnecessary intervention (as the drains should be working appropriately with any added suction being indicated).There was no harm to the patient, however it is of great importance that the drains be on suction due to the nature of the surgery, the changing of the drainage bottle increases the risk of infection to the patient despite the procedure being done using antt/ in a sterile field.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.

• Brand Name: ARGYLE ALTITUDE DRY SUCT C D U
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 18981914
• Report Number: 9611018-2024-00015
• Device Sequence Number: 6666028
• Product Code: FCM
• UDI-Device Identifier: 10884521060975
• UDI-Public: 10884521060975
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/10/2024

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: 8888571370
• Device Catalogue Number: 8888571370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/10/2024
• 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