MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; YANKAUER FROM OPEN HEART PACK

Catalog Number	DYNJ55533A
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the yankauer (from open heart pack) broke during the procedure.It is unknown what were the events leading up to the incident.There is no additional information available to determine how the reported event affected the patient, the staff, the procedure, or the total length of the procedure.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was returned for evaluation and it was confirmed that the yankauer's flanged tip broke off.The custom surgical kit component placement was reviewed and was determined not to be a cause for reported issue.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the yankauer broke during the procedure.

• Common Device Name: YANKAUER FROM OPEN HEART PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8110308
• Report Number: 1423395-2018-00062
• Device Sequence Number: 14033733
• Product Code: LRO
• UDI-Device Identifier: 10888277759046
• UDI-Public: 10888277759046
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

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: Health Professional
• Device Catalogue Number: DYNJ55533A
• Device Lot Number: 18GBT374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/28/2018
• 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: Other