MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MEDI-VAC YANKAUER SUCTION HANDLE W/BULBOUS TIP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Lot Number 1929508764 & 2113207864

Device Problems Break (1069); Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 12/26/2021

Event Type  malfunction  

Event Description

During intubation, physician attempted to suction and tip of yankauer broke off and was stuck at back of the patient's throat.Physician able to retrieve broken piece with some difficulty.Upon inspection of inventory, it was found other yankauer sunction handles had cracks near the tip.

• Brand Name: MEDI-VAC YANKAUER SUCTION HANDLE W/BULBOUS TIP
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 13223858
• MDR Text Key: 283610257
• Report Number: 13223858
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/07/2022,01/04/2022

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 Lot Number: 1929508764 & 2113207864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2022
• Date Report to Manufacturer: 01/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1