MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LHK-,HMWB/HMTW HOSPITAL

Catalog Number	VASC1307
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the control syringe also started to back off the manifold during the setup and would unravel itself.".
Additional Manufacturer Narrative
The customer reported control syringe coming disconnected from manifold, and additional information stated the control syringe started to back off the manifold during setup; no patient involvement, impact, serious injury, medical intervention, or follow-up care was reported.A used sample was returned for evaluation; visual evaluation did not reveal any defects, and the syringe and manifold were connected and used to attempt a replication of the same defect the customer experienced.In each of the three connection attempts, the syringes backed off/rolled free of the manifold connection, thereby replicating the reported defect, and the customer complaint was confirmed with the returned samples.Root cause investigation determined excess silicone from the rotating adapter swage machine migrated onto the syringe luer, and the combination of excess silicone on the luer with saline in the syringe reduced the friction fit of the luer lock enough to cause the syringe/manifold connection to disconnect during use.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: DBD-LHK-,HMWB/HMTW HOSPITAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946465
• Report Number: 1417592-2026-54265
• Device Sequence Number: 15827396
• Product Code: OEZ
• UDI-Device Identifier: 40195327057856
• UDI-Public: 40195327057856
• 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: VASC1307
• Device Lot Number: 24ABC832
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2024
• 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: 04/10/2024
• Initial Report FDA Received Date: 09/30/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown