MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; VACUUM TUBE HOLDER

Catalog Number	DYNDBCHLDR
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the hub is narrower, the rubber sheath on the needle does not fully retract when placed in the hub and on occasion the tube is not easily removed from the needle.In the picture below, the cap remained on the needle resulting in loss of blood" and "blood splatter is being left on the caps.".
Additional Manufacturer Narrative
The customer reported receiving a medline tube holder that doesn¿t retract, with the hub narrower, the rubber sheath on the needle not fully retracting when placed in the hub, the tube not easily removed from the needle on occasion, the cap remaining on the needle resulting in loss of blood, and the patient had to be recollected.Medline received 23 dyndbchldr blood collection tube holders; visual inspection revealed no manufacturing defects preventing the samples from working properly, and functional testing utilizing a venipucture blood board observed for fluid leakage and tested the diameter of the tube holder to ensure the tubes were able to be removed.Medline was not able to simulate the error that occurred during customer use, the tubes were able to be removed without any narrowness of the tube holders, and no leakage was observed during or before the simulated blood removal process; however, the complaint was confirmed via photograph, with evidence that the tube cap came off and was stuck inside the tube holder.Per the vendor, feedback photo analysis found the blood collection tube cover stuck in the tube holder, with inference due to incompatibility between the blood collection tube and the puncture needle, and stated this is not a defect caused by product manufacturing issues; 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
• Common Device Name: VACUUM TUBE HOLDER
• 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: 50931738
• Report Number: 1417592-2026-52947
• Device Sequence Number: 10759223
• Product Code: KST
• UDI-Device Identifier: 10888277415461
• UDI-Public: 10888277415461
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/28/2026

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: DYNDBCHLDR
• Was Device Available for Evaluation?: Yes
• 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: 12/26/2024
• Initial Report FDA Received Date: 09/29/2026
• 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