MAUDE Adverse Event Report: CARDINAL HEALTH 5010-TS YANKAUER SUC TUBE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888501031
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2022
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 that during a thoracoscopy, during normal use of the suction cup, a piece of the basket broke off at the tip in the patient.
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.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to confirm the reported condition, determine the root cause(s), or implement any corrective action(s).If a sample is returned at a later date, the complaint will be reopened, and the investigation will be updated to reflect our findings.This complaint will be used for tracking and trending purposes.

• Brand Name: 5010-TS YANKAUER SUC TUBE
• 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: 14279348
• Report Number: 9611018-2022-00558
• Device Sequence Number: 12105753
• Product Code: GCX
• UDI-Device Identifier: 10884527019854
• UDI-Public: 10884527019854
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 06/07/2022

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: 8888501031
• Device Catalogue Number: 8888501031
• Device Lot Number: 21G084FHX
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/14/2022
• 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