MAUDE Adverse Event Report: HALYARD HEALTH, INC. HALYARD; CATHETER AND TIP, SUCTION

Model Number	97021
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While performing mouth care on an intubated patient, the swab snapped when the patient closed their mouth.Sponge tip retrieved with yankauer, and kelly clamp from back of patient's mouth.

• Brand Name: HALYARD
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7185346
• Report Number: 7185346
• Device Sequence Number: 16159121
• Product Code: JOL
• UDI-Device Identifier: 20680651970217
• UDI-Public: (01)20680651970217
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2018
• Report Date (Section F): 01/08/2018

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
• Operator of Device: Nurse
• Device Expiration Date: 01/28/2019
• Device Model Number: 97021
• Device Catalogue Number: 97021-02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUCTION
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/08/2018