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

Model Number 8888501031

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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
• 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: 14279348
• MDR Text Key: 299570209
• Report Number: 9611018-2022-00558
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10884527019854
• UDI-Public: 10884527019854
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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
• Date Manufacturer Received: 04/13/2022
• 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