MAUDE Adverse Event Report: Medline Industries, LP MEDLINE CO-LABEL; DBD-CENTRIFUGE,COAG,FIXED ROTOR,12X75MM

Catalog Number	MLAB67621500
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that item did not turn off at the times stated.Cst stated that the two minute option was running three minutes before turning off.The three minute option would run four minutes, and the five minute option six minutes.
Additional Manufacturer Narrative
The customer stated that the item did not turn off at the times stated; the two minute option was running three minutes before turning off, the three minute option would run four minutes, and the five minute option six minutes.Medline received 1ea dash coag stat centrifuge, performed visual inspection with no noticeable cosmetic damage, and proceeded to do functional testing by plugging in the centrifuge to the power and each setting to its max allowed time of 2, 3, and 5 min.During testing, each time setting would go passed the time it was set too by almost a minute to almost two minutes, and the complaint was confirmed.No root cause was identified in the record; a retrospective review of the past 12 months indicated no prior complaints in regards to this issue and no known trends for this product or lot, and the division will continue to monitor the issue for trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE CO-LABEL
• Common Device Name: DBD-CENTRIFUGE,COAG,FIXED ROTOR,12X75MM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754200
• Report Number: 1417592-2026-39184
• Device Sequence Number: 9241545
• Product Code: JQC
• UDI-Device Identifier: 00810052862873
• UDI-Public: 00810052862873
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/11/2026

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: MLAB67621500
• Device Lot Number: 048319
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/22/2024
• 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: 03/15/2024
• 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): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown