MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-OUTPATIENT GREATER THAN 5

Catalog Number	DYNDV2136C
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "stopcock 3 way in this kit leaks from the bottom component".
Additional Manufacturer Narrative
The customer reported a product failure and stated that the stopcock 3 way in the kit leaks from the bottom component; the customer also stated, "no pt.Harm".A sample was received for investigation, consisting of one stopcock, and the rest of the pack was not received; medline observed no visual defects or abnormalities with the received sample, reviewed finished good production records and pack build, and observed under magnification a crack in the plastic in the bottom compartment.The reported issue was confirmed.Medline stated that the item is received from the vendor and is not altered during kit assembly, that the nature of the damage indicates a potential molding defect, and that the root cause is related to an error in the component manufacturing process; the component manufacturing facility identified the leaking as caused by a mold deviation leading to uneven wall thickness and is correcting the mold issue and increasing inspection to prevent recurrence.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-OUTPATIENT GREATER THAN 5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50931797
• Report Number: 1417592-2026-52890
• Device Sequence Number: 10734787
• Product Code: LRS
• UDI-Device Identifier: 40195327065561
• UDI-Public: 40195327065561
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/25/2026

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: DYNDV2136C
• Device Lot Number: 22KBJ013
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2023
• 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: 03/14/2023
• Initial Report FDA Received Date: 09/29/2026
• 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