MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-GEN LAPAROSCOPY PACK

Catalog Number	DYNJ82300B
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that steristrip leaking and leaking onto/damage to trocar within pack (cannot be used).
Additional Manufacturer Narrative
The customer/reporter described the issue as steristrip leaking and leaking onto/damage to trocar within pack (cannot be used).Medline received two photos and no physical sample was available; upon inspection of the photos, an orange stain was shown on the packaging of another component, and the finished good production records and finished good pack build were reviewed.Based on the information and photos provided, medline confirmed the steristrip leaked onto the trocar packaging; the steristrip was originally packaged by the vendor but is removed during the pack assembly as per request, and medline was unable to confirm whether the leak occurred during the sterilization process, pack assembly, or shipping.Medline confirmed the reported issue as vendor product issue related to the component manufacturing process; an engineering change notice was completed to keep the steristrip inside its packaging, the complaint was provided to the vendor for further evaluation, and the risk assessment found the incident acceptable.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-GEN LAPAROSCOPY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50221520
• Report Number: 1417592-2026-15833
• Device Sequence Number: 10337213
• Product Code: FDE
• UDI-Device Identifier: 10198459003202
• UDI-Public: 10198459003202
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/12/2026

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: DYNJ82300B
• Device Lot Number: 24FMB517
• 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: 05/05/2025
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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