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

Catalog Number	DYNJ85517
Medical Device Problem Codes	Fluid/Blood Leak (1250); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the chloraprep popped.
Additional Manufacturer Narrative
The account reported finding chloraprep preactivated.A sample was received; medline received one unopened pack, observed through the breather pouch an orange stain on the back table cover, opened the pack, reviewed finished good production records, and reviewed the finished good pack build.The reported issue was confirmed: the chloraprep had orange staining inside of its original packaging, and after further examination the handle was compressed causing the chloraprep to activate.There were no line down situations, run without approvals, deviations, non-conformance reports, or build issues that likely contributed to the reported issue; the placement of the chloraprep in the pack was determined to provide adequate protection from pre-activation, and the complaint was provided to the vendor for further evaluation while supplier quality 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-GENERAL LAPAROSCOPY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50849949
• Report Number: 1417592-2026-47221
• Device Sequence Number: 10026188
• Product Code: LRO
• UDI-Device Identifier: 40195327511600
• UDI-Public: 40195327511600
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/21/2026

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: DYNJ85517
• Device Lot Number: 24CBR887
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2024
• 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: 06/19/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown