MAUDE Adverse Event Report: CARDINAL HEALTH SENTINEL SEAL CDU; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888571562
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the gauge of the connector was too small and several chest tubes have already fallen off the new devices several times.Per customer, the back door in the box opens easily and exposes the water seal chamber and they are complicated to use as a result it was easily contaminated and not sterile.There was no patient harm reported.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was not received for the investigation.A gemba walk was carried out in the manufacturing line, all process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.From the description of the complaint, the manufacturing site believes that the issue is in relation to training.All sentinel seal and other cdu units are sterile, the vessels are wrapped in blue wrap, then placed in a header bag then sterilized.The customer talks about the gauge of the connector are too small and several chest tubes have already fallen off.The connector on the cdu vessels is part of the design and design has not changed, also the ifu for this sku states in section d: sentinel seal¿ cdu operation.Remove protective cover from patient connector and connect to patient¿s thoracic catheter.For improved flow, connector may be cropped to match catheter size and taped to secure.The customer talks ¿backdoor opens easily¿, this reads like it is the fill spout which is part of the design of the vessels and has been on the vessels for many years.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: SENTINEL SEAL CDU
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 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: 19658934
• Report Number: 1423537-2024-00058
• Device Sequence Number: 6632551
• Product Code: GCX
• UDI-Device Identifier: 10884521061026
• UDI-Public: 10884521061026
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8888571562
• Device Catalogue Number: 8888571562
• Device Lot Number: 23A005FHX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown