MAUDE Adverse Event Report: CARDINAL HEALTH FLEXIBLE YANKAUER REGULAR CAPA; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888501007
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
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 during the aspirations of liquids in the abdomen, the cannula was blocked several times with solid particle materials and did not aspirate adequately.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.No sample was available for evaluation.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).If a sample should be returned later, this complaint will be reopened, and the investigation updated to reflect our findings.A review of the manufacturing line was completed, and no issue were detected during this review.At this time, a corrective and preventative action (capa) will not be initiated.This complaint will be used for tracking and trending purposes.

• Brand Name: FLEXIBLE YANKAUER REGULAR CAPA
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• 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: 15825101
• Report Number: 9611018-2022-00568
• Device Sequence Number: 17641901
• Product Code: GCX
• UDI-Device Identifier: 10884527019823
• UDI-Public: 10884527019823
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/19/2022

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: 8888501007
• Device Catalogue Number: 8888501007
• Device Lot Number: 22G068FHX
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/19/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown