MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-OPEN HEART PACK

Catalog Number	DYNJ04649L
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, during a coronary artery bypass graft procedure on (b)(6) 2023 the "plastic tip separated from the metal shaft" of the "intracardiac sucker" and "fell into the patient".
Additional Manufacturer Narrative
According to the customer, during a coronary artery bypass graft procedure on (b)(6) 2023 the "plastic tip separated from the metal shaft" of the "intracardiac sucker" and "fell into the patient".The customer reported surgeon removed the tip from the patient and was able to account for all the "dislodged parts".According to the customer there was no serious injury identified, follow up care needed, or medical intervention required related to the reported incident.The customer reported the procedure was able to be completed.No additional information is available at this time.Sample requested for return evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Common Device Name: DBD-OPEN HEART PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17930802
• Report Number: 1423395-2023-00058
• Device Sequence Number: 6455354
• Product Code: OEZ
• UDI-Device Identifier: 10888277744578
• UDI-Public: 10888277744578
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ04649L
• Device Lot Number: 21KMB677
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown