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

Catalog Number	DYNJ52212F
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	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we received 4 universal packs today via fed ex with one of the packs having the chloraprep activated inside.".
Additional Manufacturer Narrative
The customer reported one of the packs having the chloraprep activated inside, and the complaint noted that the issue did not occur during use and no injury occurred.A photo was received showing orange-colored leakage inside an unopened kit; finished good production records and finished good pack build were reviewed, and no issues were identified that could have contributed to the reported issue.The leakage appears to have originated from the chloraprep pad, with visible signs of the solution having leaked through its packaging, confirming the reported issue.The root cause is classified as non-pack related, and it is possible that the concern originated from handling during transit or unpacking; this complaint has been provided to the vendor for further evaluation, 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-UNIVERSAL RECOVERY 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: 50854953
• Report Number: 1417592-2026-47616
• Device Sequence Number: 9508633
• Product Code: LRO
• UDI-Device Identifier: 10198459300363
• UDI-Public: 10198459300363
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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: DYNJ52212F
• Device Lot Number: 25GDB056
• 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: 08/08/2025
• Initial Report FDA Received Date: 09/22/2026
• 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