MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; OPEN HEART

Model Number	CDS985504G
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 during an open heart surgical case the raytec sponge fractured during use and was leaving sponge fragments in the patient that needed to be removed by the surgeon.Per the facility the surgeon irrigated with antibiotic irrigation solution, and to this point the patient is reported to be doing fine.The sample was returned for evaluation and at this time a definitive root cause could not be determined.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on (b)(6) 2022 during an open heart surgical case the raytec sponge fractured during use and was leaving sponge fragments in the patient that needed to be removed by the surgeon.

• Brand Name: Medline Industries, Inc.
• Common Device Name: OPEN HEART
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15754983
• Report Number: 1423395-2022-00036
• Device Sequence Number: 14170280
• Product Code: OEZ
• UDI-Device Identifier: 10195327150822
• UDI-Public: 10195327150822
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2022

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 Model Number: CDS985504G
• Device Catalogue Number: CDS985504G
• Device Lot Number: 22DBO976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown