MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY,SKIN SCRUB,WET,STANDARD

Catalog Number	DYND70372
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have two wet skin prep trays, dynd70372, that were not sealed properly.When they were picked up from the shelf to be pulled for an or case the seam split.".
Additional Manufacturer Narrative
The customer reported that they had two wet skin prep trays that were not sealed properly and, when they were picked up from the shelf to be pulled for an or case, the seam split.Medline quality received 2 ea of the item for evaluation, and visual inspection was conducted with the provided samples; it was found that the provided samples are not sealed properly.The reported concern was confirmed, as the seam is split.The suspected root cause is a manufacturing issue, the manufacturing site has been notified of this issue, and the division will continue to monitor the issue for trending.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: TRAY,SKIN SCRUB,WET,STANDARD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50719508
• Report Number: 1417592-2026-36322
• Device Sequence Number: 10056587
• Product Code: OJU
• UDI-Device Identifier: 40080196945802
• UDI-Public: 40080196945802
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/07/2026

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: DYND70372
• Device Lot Number: 11022100386
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2023
• 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: 04/05/2023
• Initial Report FDA Received Date: 09/10/2026
• 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