MAUDE Adverse Event Report: Medline Industries, LP - SPT Medline; ELECTROPHYSIOLOGY TRAY-LF

Catalog Number	DYNJ09878F
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: ELECTROPHYSIOLOGY TRAY-LF
• Manufacturer (Section D): Medline Industries, LP - SPT; 1170 s northpoint boulevard; waukegan IL 60085 -675
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50509805
• Report Number: 1423395-2026-00584
• Device Sequence Number: 9525690
• Product Code: LRO
• UDI-Device Identifier: 10198459051098
• UDI-Public: 10198459051098
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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): 08/28/2026

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: DYNJ09878F
• Device Lot Number: 26GBD110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown