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

Catalog Number	DYNJ83275
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "several packs appear to be improperly sealed, which raises potential sterility and handling issues.".
Additional Manufacturer Narrative
It was reported that the sealing of the custom hand packs and photos of slipped/misplaced/separated thl's; the account reported finding tear here label slipped/misplaced.A photo was received for the investigation, and in the photos it was observed that both tear here labels were no longer securing the end folds of the back table cover; finished good production records and finished good pack build were reviewed, and no other issues were identified with the pack.Based on the photos provided, medline confirmed that the tear here labels had slipped, and the cause was documented as supplier error/mfg: material composition non-asia (medline brnd).Tear here labels do not establish sterility and are intended to hold the pack contents together, and the division 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: HAND PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50818738
• Report Number: 1417592-2026-44656
• Device Sequence Number: 10680839
• Product Code: OJH
• UDI-Device Identifier: 10195327255466
• UDI-Public: 10195327255466
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/17/2026

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: DYNJ83275
• Device Lot Number: 25FBH997
• 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: 09/11/2025
• Initial Report FDA Received Date: 09/18/2026
• 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