MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; BASIN ST MAJOR-NO CAUTERY

Model Number DYNJ907722B

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Per the facility gauze fibers are falling off into the patient cavity during surgery.

Manufacturer Narrative

Per the facility gauze fibers are falling off into the patient cavity during surgery.No additional information is available at this time.The sample is not available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

• Brand Name: Medline Industries, Inc.
• Type of Device: BASIN ST MAJOR-NO CAUTERY
• 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: 17033125
• MDR Text Key: 316278924
• Report Number: 1423395-2023-00025
• Device Sequence Number: 1
• Product Code: KDD
• UDI-Device Identifier: 10195327129262
• UDI-Public: 10195327129262
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYNJ907722B
• Device Catalogue Number: DYNJ907722B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other