MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DEVICE,ACCESS,20MM,MULTI-DOSE VIAL

Catalog Number	DYNDTN0601ACS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿access devices are defective and are causing vials to leak and therefore causing the studio to have to waste vials due to sterility concerns.¿.
Additional Manufacturer Narrative
The account reported finding leaking vials and stated that the studio had to waste vials due to sterility concerns.Customer samples were delayed en route for evaluation and never arrived; the division pulled 5ea for evaluation, connected the access device to a vial of liquid, connected a syringe, flipped the unit upside down, and began to pull fluid from the vial into the syringe.After the syringe was disconnected, fluid appeared to leak from the vial, and based on the complaint details, sample evaluation, and investigation, the complaint can be confirmed.The vendor did not find any discrepancies in their production records that could have contributed to the reported issue, the cause was documented as cannot determine cause, and the division will monitor this issue for trending purposes.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: DEVICE,ACCESS,20MM,MULTI-DOSE VIAL
• 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: 50872322
• Report Number: 1417592-2026-49281
• Device Sequence Number: 18806890
• Product Code: FPA
• UDI-Device Identifier: 10884389191002
• UDI-Public: 10884389191002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052790
• 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): 09/23/2026

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: DYNDTN0601ACS
• Device Lot Number: 24105197
• 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: 04/16/2025
• Initial Report FDA Received Date: 09/23/2026
• 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