MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; DBD-MINOR BASIN

Catalog Number	DYNJ44558B
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, the "fibers" were noted in the surgical site on (b)(6) 2025 after using the "raytec" to "blot blood that was in the incision area".The customer stated that the incident happened twice with the "same pack of raytec" during a procedure.The customer reported after the fibers were identified the "material was removed with forceps", and the area was "irrigated and suctioned".The customer reported that there was "no impact to patient", and the procedure was able to be completed.The customer reported did not report any serious injury related to the reported incident.No additional details are available related to the customer reported issue.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 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 customer, the "fibers" were noted in the surgical site on (b)(6) 2025 after using the "raytec" to "blot blood that was in the incision area".

• Brand Name: MEDLINE
• Common Device Name: DBD-MINOR BASIN
• 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: 23751911
• Report Number: 1423395-2025-00199
• Device Sequence Number: 9584065
• Product Code: KDD
• UDI-Device Identifier: 10195327177560
• UDI-Public: 10195327177560
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ44558B
• Device Lot Number: 25EBL583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2025
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 93 KG