MAUDE Adverse Event Report: CARDINAL HEALTH RIGID YANKAUER SET 10'; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888505040
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that they had a patient end up with wounds behind their mouth after using this suction tip.The suction tip has holes on the side near the tip that are cut so that the edges of the holes are sharp.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported that they had a patient end up with wounds behind their mouth after using this suction tip.The suction tip has holes on the side near the tip that are cut so that the edges of the holes are sharp.The device history record (dhr) review was unable to be performed as the reported lot number was unknown.Failure mode trending was reviewed and no related adverse trends were identified.The reported device was not returned for evaluation; therefore, the reported device failure was not confirmed.Current process controls are executed in accordance with product specifications to meet quality acceptance criteria.Additional action will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: RIGID YANKAUER SET 10'
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12738902
• Report Number: 9612030-2021-03075
• Device Sequence Number: 1440104
• Product Code: GCX
• UDI-Device Identifier: 10884527019977
• UDI-Public: 10884527019977
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 8888505040
• Device Catalogue Number: 8888505040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/18/2021
• 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