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

Catalog Number	DYNJ81739
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "as we have been un boxing the latest shipment we are finding a pretty significant number of packs that have holes/tears in the packaging compromising the sterility of the pack.There have also been instances where the surgical team has opened the packs and found that the larger table drape has had a hole in it.".
Additional Manufacturer Narrative
The account reported finding holes in breather pouches, and the complaint stated that packs had holes/tears in the packaging compromising the sterility of the pack and that the larger table drape had a hole in it.A sample of the pack was received for investigation, but the original case and the rest of the packs were not received; physical inspection of the received sample found that the edge of the pack appeared to have holes, finished good production records showed no line downs or non-conformance that might have had an impact, and the pack component locations likely did not contribute to the issue.The reported problem was confirmed on the received sample, but medline was unable to determine the original location where the damage occurred.Based on the complaint details, the pack was caught and snagged on an outside source at some point during production, transit, or storage, 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.

• Brand Name: MEDLINE
• Common Device Name: DBD-LS PREP PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897200
• Report Number: 1417592-2026-50824
• Device Sequence Number: 5829401
• Product Code: FMH
• UDI-Device Identifier: 40195327138296
• UDI-Public: 40195327138296
• 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): 09/24/2026

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: DYNJ81739
• Device Lot Number: 22FBW626
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/05/2023
• 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: 05/02/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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