MAUDE Adverse Event Report: Medline Industries, LP MEDLINE CO-LABEL; CENTRIFUGE,614B,FIXED,1 SPEED,6X75-125MM

Catalog Number	MLAB00421500
Medical Device Problem Codes	Mechanical Problem (1384); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE CO-LABEL
• Common Device Name: CENTRIFUGE,614B,FIXED,1 SPEED,6X75-125MM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50756938
• Report Number: 1417592-2026-39631
• Device Sequence Number: 13048673
• Product Code: JQC
• UDI-Device Identifier: 00810052862347
• UDI-Public: 00810052862347
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 09/09/2026

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: MLAB00421500
• Device Lot Number: 045961
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown