MAUDE Adverse Event Report: MEDLINE - MEXICALI MEDLINE; DBD-PACEMAKER 116121

Catalog Number	DYNJ37388O
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Busted chloraprep.
Additional Manufacturer Narrative
It was reported that the chloraprep was busted.Product was given to materials and busted container was reported.There were no reports of death, serious injury, medical intervention, or follow up care.

• Brand Name: MEDLINE
• Common Device Name: DBD-PACEMAKER 116121
• Manufacturer (Section D): MEDLINE - MEXICALI; calle circuito del desierto 71; mexicali; baja california, 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25195133
• Report Number: 1423395-2026-00161
• Device Sequence Number: 10565668
• Product Code: OEZ
• UDI-Device Identifier: 10198459362729
• UDI-Public: 10198459362729
• 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): 05/16/2026

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: DYNJ37388O
• Device Lot Number: 25KMC376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2025
• 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