MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - MEXICALI MEDLINE; CARDIAC CATH PACK

Catalog Number	DYNJ44907C
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the pack was opened and team noticed that the prep stick was already activated, so another stick was retrieved from the inventory.There was no injury, and no follow-up care, medical, and/or surgical intervention or treatment required.
Event or Problem Description
Chloraprep activated in pack, spilled in kit.

• Brand Name: MEDLINE
• Common Device Name: CARDIAC CATH PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - MEXICALI; calle circuito del desierto #7; parque industrial del desierto; mexicali, baja california, 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25027332
• Report Number: 1423395-2026-00077
• Device Sequence Number: 13092162
• Product Code: OES
• UDI-Device Identifier: 10198459285943
• UDI-Public: 10198459285943
• 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
• Report Date (Section B): 04/29/2026

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: DYNJ44907C
• Device Lot Number: 25KMH809
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2025
• 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