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

Model Number CDS985504G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2022

Event Type  Injury  

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 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.
• Type of Device: 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
• MDR Text Key: 303268472
• Report Number: 1423395-2022-00036
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 10195327150822
• UDI-Public: 10195327150822
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention