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

Catalog Number	DYNJ33450F
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	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported: "customer had a busted chloraprep that contaminated pack," and the investigation summary states the account reported finding pre-activated duraprep.A photo and a sample were received; the sample was of one unopened pack, there was an orange spot on the pack insert, and when the pack was opened the duraprep was pre-activated and leaked in the pack; finished good production records and the finished good pack build were reviewed.The reported problem was confirmed, and reviewed production records noted no non-conformances that would have contributed to the reported issue.The placement of the duraprep in the pack was reviewed and its location was determined to have contributed to the pre-activation as it was not adequately protected; the component's placement could be changed to prevent recurrence in the future, 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.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.
Event or Problem Description
It was reported that "customer had a busted chloraprep that contaminated pack.".

• Brand Name: MEDLINE
• Common Device Name: DBD-SHOULDER PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947017
• Report Number: 1417592-2026-54374
• Device Sequence Number: 9499642
• Product Code: OJH
• UDI-Device Identifier: 40195327213405
• UDI-Public: 40195327213405
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/29/2026

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: DYNJ33450F
• Device Lot Number: 22JBG007
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2023
• 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: 05/16/2023
• Initial Report FDA Received Date: 09/30/2026
• 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