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

Catalog Number	DYNJ908021A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "component leaked.".
Additional Manufacturer Narrative
The account reported finding leaking component, and the complaint email described the pack as having components burst before opening.A photo and a sample were received for investigation; three photos and 2 unopened pack samples were received, both packs were opened, pvp stains were observed in the outer fold of the pack, the cap was slightly loose, no damage was found with the pvp bottle, and there were no issues noted with the breather pouch or the back table cover.The investigation confirmed pvp stains in the outer fold of the pack and a slightly loose cap, but with the information provided, medline was not able to confirm at what point during the pack's lifecycle the leaking occurred or what may have caused it; based on the component's location in the pack it is unlikely that placement contributed to the reported issue.This complaint has been provided to the component manufacturing facility for further evaluation, and the supplier quality team 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-LAMINECTOMY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50790678
• Report Number: 1417592-2026-42470
• Device Sequence Number: 13404645
• Product Code: OJH
• UDI-Device Identifier: 40195327376100
• UDI-Public: 40195327376100
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/15/2026

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: DYNJ908021A
• Device Lot Number: 22LBQ285
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/18/2023
• 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: 05/15/2023
• Initial Report FDA Received Date: 09/16/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown