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

Catalog Number DYNJ55533A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/29/2018

Event Type  malfunction  

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 Description

It was reported that the yankauer broke during the procedure.

• Type of Device: YANKAUER FROM OPEN HEART PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8110308
• MDR Text Key: 128749285
• Report Number: 1423395-2018-00062
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888277759046
• UDI-Public: 10888277759046
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other