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

Catalog Number	DYNJ55855B
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	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that clinic received damaged product.Both of them had the chloraprep sticks on the back that came in burst.
Additional Manufacturer Narrative
The account reported finding preactivated chloraprep, and the complaint transcript states the clinic received damaged product and both had the chloraprep sticks on the back that came in burst.A photo was received for the investigation; the photos were up-close photos of the pack, finished good production records were reviewed, the finished good pack build was reviewed, and trending was reviewed.Based on the complaint details, photo evaluation, and investigation, medline confirmed the reported issue; the photos clearly showed the chloraprep was activated inside the packaging and poly bag.The placement of the chloraprep in the pack was reviewed and determined to provide adequate protection from pre-activation, and it is possible that the activation point may inadvertently become compressed and the component activated at some point during transit or storage; the complaint was provided to the vendor for further evaluation and 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-BSC HAND PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50690700
• Report Number: 1417592-2026-34637
• Device Sequence Number: 5975579
• Product Code: OJH
• UDI-Device Identifier: 40193489850827
• UDI-Public: 40193489850827
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/04/2026

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: DYNJ55855B
• Device Lot Number: 23HDB155
• 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: 11/06/2023
• Initial Report FDA Received Date: 09/09/2026
• 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