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

Model Number	8888571562
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer states the cdu was leaking at the collection chamber.The target vacuum wasn't reached.This happened during use on a patient and there was no injury.The unit was switched with another without any issue.
Additional Manufacturer Narrative
The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Three (3) unopened representative samples were received.Upon visual inspection no issues were observed.All 3 returned samples were tested as per product specifications for sentinel seal / sentinel seal dual c.D.U function test.A series of tests were performed on the 3 units and all 3 devices met all functional requirements.Based on the 3 returned samples this compliant cannot be confirmed as this time.A risk assessment was deemed not required as the investigation did not confirm that the reported issue was related to a manufacturing process.Further monitoring will be performed via trending within the scope of post market surveillance.At this time, a corrective/preventative action (capa) is not required as the complaint samples and dhr did not indicate a device related issue.

• Brand Name: SENTINEL SEAL CDU
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• 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 street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13009872
• Report Number: 9611018-2021-00544
• Device Sequence Number: 5441290
• Product Code: GCX
• UDI-Device Identifier: 10884521061026
• UDI-Public: 10884521061026
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/08/2022

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: 8888571562
• Device Catalogue Number: 8888571562
• Device Lot Number: 21H004FHX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/08/2022
• 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