MAUDE Adverse Event Report: MEDLINE - MEXICALI MEDLINE; BASIC LAP PACK

Catalog Number	DYNJ85215
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a pack was used on a patient that showed an expiration date of 8/31/2025 on the outside of the pack.The kitting team informed me that the whole pack is expired, then later reached out saying it only applies to certain items in the kit.Upon further discussion with the account, the materials manager informed me that the pack did come with a yellow sticker on the outside, but it was the scrub tech who opened the pack and the administrator and higher-ups did not see this sticker since it was already opened.Everything is fine.The expired item in the pack was not used on a patient.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.
Event or Problem Description
Expired pack used on a patient.

• Brand Name: MEDLINE
• Common Device Name: BASIC LAP PACK
• Manufacturer (Section D): MEDLINE - MEXICALI; calle circuito del desierto 71; baja california, 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25263333
• Report Number: 1423395-2026-00179
• Device Sequence Number: 18578328
• Product Code: FDE
• UDI-Device Identifier: 10195327476885
• UDI-Public: 10195327476885
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: DYNJ85215
• Device Lot Number: 24DMK222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/23/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown