MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC MEDLINE INDUSTRIES, INC.; YANKAUER FLANGE TIP ON/OFF

Model Number	CDS981533F
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the suction tip broke off in the patient.The patient was having heart surgery when the reported incident occurred.Reportedly, the patient had to go under additional general anesthesia and had an x-ray to make sure the foreign body was retrieved from the patient.Due to the reported statement that the patient needed additional medical intervention and in an abundance of caution, this is a reportable mdr event.The sample was returned for evaluation.Upon inspection of the received sample it was seen that the top section of the yankauer broke off and left a jagged end on the yankauer, the end was not sent with the yankauer.The customer did note that when the tip broke it broke into multiple piece.No root cause was determined.No additional information is available.If additional information becomes available this report will be re-opened and re-evaluated.
Event or Problem Description
It was reported that during a heart surgery procedure, the yankauer suction tip broke off in the patient.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: YANKAUER FLANGE TIP ON/OFF
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; three lakes drive; northfield, il
• MDR Report Key: 10148589
• Report Number: 1423395-2020-00010
• Device Sequence Number: 3852845
• Product Code: OEZ
• UDI-Device Identifier: 10889942643691
• UDI-Public: 10889942643691
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CDS981533F
• Device Catalogue Number: CDS981533F
• Device Lot Number: 19LB0186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention