MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BLD COLL SET, 21GX0.75, HOLDER

Catalog Number	OGBCS21GT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "ogbcs21gt leaking while in use" and "the pluger component of the item was loose causing collected blood to leak.".
Additional Manufacturer Narrative
The customer reported receiving a medline blood collection set holder that was leaking during use, and that the plunger component of the item was loose causing collected blood to leak; per the facility, only patient impact was an "unsuccessful draw, patient needs to come back for a redraw," and the user was evaluated by eodh.At this time, a sample(s) was not received for investigation; investigation included review of recent complaint trends/scar activity for the last three trend reports, and the vendor reported that through sample investigation, dhr review, and batch verification, no abnormalities were found.The investigation results were unconfirmed, and medline was unable to confirm the complaint issue or that the product failed to meet specifications because there were no samples, photos, videos, or other critical details provided.The root cause of the non rebound of the rubber cap was not found; product quality meets the requirements of product specifications, and division will continue to monitor trends.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
• Common Device Name: BLD COLL SET, 21GX0.75, HOLDER
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: cyrus johnson ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754521
• Report Number: 1417592-2026-39236
• Device Sequence Number: 18447675
• Product Code: FPA
• UDI-Device Identifier: 10197344112074
• UDI-Public: 10197344112074
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151991
• 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: OGBCS21GT
• Device Lot Number: 250401
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2025
• 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: 09/03/2025
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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