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

Catalog Number	DYNJ81684D
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	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "a chloraprep exploded inside a pack ruining the pack.".
Additional Manufacturer Narrative
The customer reported a chloraprep exploded inside a pack, ruining the pack.No sample or photo was received for the investigation; the pack production record was unable to be reviewed due to no lot number being provided, and the general pack build was reviewed, which showed one chloraprep app 26ml orange was to be present within the pack and placed in the outerfold away from the interior components and subassemblies.Based on the complaint details, medline was not able to confirm the defect as there were no samples or a detailed picture received for this complaint investigation.The cause was documented as sample required to determine cause, and this 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-OASIS BASIN PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sanadadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50772958
• Report Number: 1417592-2026-40500
• Device Sequence Number: 9717619
• Product Code: KDD
• UDI-Device Identifier: 40195327486380
• UDI-Public: 40195327486380
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/02/2026

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: DYNJ81684D
• Was Device Available for Evaluation?: No
• 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: 08/28/2024
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown