MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-DR. ANDREW'S KIT

Catalog Number	DYNJ54472B
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the duraprep exploded inside the pack.
Additional Manufacturer Narrative
The account reported finding duraprep leaked inside pack.A photo was received for the investigation, and the account sent in a sample for review; the sample was of one open pack with brown staining in the pack, and two out of the five durapreps leaked in the vendor package.Finished good production records were reviewed and no non-conformances were noted that would have contributed to the reported issue, and there were no issues with the pack build that might have an impact on the issue; the reported problem was confirmed by the sample evaluation.The placement of the duraprep in the pack was reviewed and determined to be in a location which provides adequate protection from pre-activation, and the investigation stated it is possible that the activation point may inadvertently become compressed and the component activated at some point during transit or storage; if recurring, change component placement, and the supplier quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.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-DR. ANDREW'S KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50776236
• Report Number: 1417592-2026-40991
• Device Sequence Number: 10528820
• Product Code: OJK
• UDI-Device Identifier: 40195327369218
• UDI-Public: 40195327369218
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/11/2026

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: DYNJ54472B
• Device Lot Number: 23CMF380
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2023
• 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: 08/09/2023
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (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