MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LAP CHOLE

Catalog Number	DYNJ906277D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during undraping the tech noticed the distal end of irrigator which is attached to the battery was leaking rusty looking saline onto the iv pole attached to the neptune suction machine." "the nurse in the room checked the hose, there was no rust particles in the saline traveling inside.".
Additional Manufacturer Narrative
According to the customer, at the end of a procedure, during undraping, it was discovered that the strykeflow 2 suction irrigator from the pack was "leaking rusty looking saline" near the battery attachment hanging on the neptune; the customer stated that "no rusty particles were in the hose" and reported no serious injury, medical intervention, or follow-up care related to the reported incident.No sample or photo was received for the investigation; the device history records were reviewed, and no non-conformances were noted that could have contributed to the reported issue, and the bill of materials was reviewed.At this time, the reported defect was unable to be confirmed, as no physical sample or detailed photographic evidence was provided to support the investigation.Sample required to determine cause; the complaint was provided to the vendor for further evaluation and the division will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-LAP CHOLE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50755840
• Report Number: 1417592-2026-39477
• Device Sequence Number: 9395901
• Product Code: FDE
• UDI-Device Identifier: 10198459117435
• UDI-Public: 10198459117435
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJ906277D
• Device Lot Number: 25FMA366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown