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

Catalog Number	DYNJ88225
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "2 ea broken.2 ea had broken chloraprep.".
Additional Manufacturer Narrative
The account reported finding chloraprep preactivated, and the customer reported that 2 ea had broken chloraprep.A photo was received for the investigation; the up-close photo was of the chloraprep and some components, with no other pack contents visible, and orange staining on the chloraprep packaging and a partially orange internal sponge were observed.Based on the investigation and photo evaluation, the reported issue was confirmed.The placement of the chloraprep in the pack was reviewed and found to be in a location that provides adequate protection from pre-activation; it is possible that the activation point may have inadvertently been compressed, causing the component to activate at some point during transit or storage, 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-BASIC PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50877370
• Report Number: 1417592-2026-49605
• Device Sequence Number: 10715922
• Product Code: LRO
• UDI-Device Identifier: 10198459122750
• UDI-Public: 10198459122750
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 09/23/2026

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: DYNJ88225
• Device Lot Number: 24JBA511
• 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: 09/16/2025
• Initial Report FDA Received Date: 09/24/2026
• 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