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

Model Number 8888571562

Device Problem Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 285417040
• Report Number: 9611018-2021-00544
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10884521061026
• UDI-Public: 10884521061026
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1