MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY,SKIN SCRUB,W/4 COMPARTMENT

Catalog Number	DYND70668
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	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the perforation at the top of the bag makes it too easy to open and the or is finding the bags open when they grab them from the supply cart.It appears the bags are opening during transit.".
Additional Manufacturer Narrative
The reported concern was regarding item dynd70668 open perforated pouch, and the customer stated the or department reported this is happening often but did not provide a quantity.The customer did not provide neither the sample nor the picture for investigation.At this time, the reported concern could not be confirmed, as we were not able to conduct the investigation; the cause was listed as unconfirmed defect, sample required to determine cause.A retrospective review of the past year indicated that there have been no prior complaints in regard to this issue for item dynd70668, and the division will continue to monitor this 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,W/4 COMPARTMENT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50859191
• Report Number: 1417592-2026-48190
• Device Sequence Number: 10026040
• Product Code: OJU
• UDI-Device Identifier: 40884389398426
• UDI-Public: 40884389398426
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/03/2026

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: DYND70668
• Device Lot Number: 11022090367
• 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: 03/29/2023
• Initial Report FDA Received Date: 09/22/2026
• 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