MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT MEDLINE; PACEMAKER PACK

Catalog Number	DYNJT4538
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a brown piece of foreign material was noted in the barrel of a bulb syringe during table set up.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a brown piece of foreign material was noted in the barrel of a bulb syringe during table set up.

• Brand Name: MEDLINE
• Common Device Name: PACEMAKER PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - SPT; 1170 s northpoint boulevard; waukegan IL 60085 6757
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25133414
• Report Number: 1423395-2026-00138
• Device Sequence Number: 18815210
• Product Code: OEZ
• UDI-Device Identifier: 10198459458262
• UDI-Public: 10198459458262
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2026

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: DYNJT4538
• Device Lot Number: 25HBM558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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