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

Catalog Number	DYNJ36979G
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there are towels that appear to the account as having more lint than typical.
Additional Manufacturer Narrative
It was reported that the towels are ¿having more lint than typical.¿ ¿we examined the front and back surface of all of the towels received and we observed no micro or macro lint or balls of lint present on the towels.¿ ¿based on the information provided and with the physical sample we received, we could not confirm the reported issue.¿ 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-X RAY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50195602
• Report Number: 1417592-2026-14904
• Device Sequence Number: 12292678
• Product Code: OEZ
• UDI-Device Identifier: 40195327148134
• UDI-Public: 40195327148134
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/10/2026

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: DYNJ36979G
• Device Lot Number: 24AMA615
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/23/2024
• 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: 05/15/2024
• Initial Report FDA Received Date: 08/10/2026
• 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