MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LAP/CHOLE PACK-LF

Catalog Number	DYNJ0589896U
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	02/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that chloraprep activated and leaked.
Additional Manufacturer Narrative
The account reported finding chloraprep preactivated.A sample pack was received; the breather pouch was already torn open, orange staining was observed on the wrapped bag, near the two tear here labels, and on the applicator, and the activator clamp had been compressed.Finished good production records were reviewed and there were no line down situations, deviations, run-withouts, or non-conformance reports that might have had an impact on this issue; finished good pack build was reviewed and placement of the chloraprep component was found to be ideal.Based on the complaint details, medline confirmed that the chloraprep had preactivated; however, it is unknown what could have caused the preactivation to occur, and the 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-LAP/CHOLE PACK-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: juan mota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50807114
• Report Number: 1417592-2026-43960
• Device Sequence Number: 10590393
• Product Code: FDE
• UDI-Device Identifier: 40195327416103
• UDI-Public: 40195327416103
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/16/2026

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: DYNJ0589896U
• Device Lot Number: 23LMA087
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/28/2024
• 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: 02/10/2024
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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