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	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "my bottles are dripping on my hands when i¿m drying vitamins up.Which if they¿re dripping out then it¿s a contamination.".
Additional Manufacturer Narrative
The customer reported bottles were dripping on hands when drying vitamins up, and according to the facility, "it slowed down on leaks".The customer did not provide the sample for evaluation, only the picture was provided, and medline was not able to investigate the issue without the physical sample.At this time, the complaint cannot be confirmed.A root cause was not identified; the division will continue to monitor this issue for trending, and there was no confirmed medical intervention or serious injury reported related to this incident.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: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50852766
• Report Number: 1417592-2026-47270
• Device Sequence Number: 15936685
• Product Code: FPA
• UDI-Device Identifier: 40884389191003
• UDI-Public: 40884389191003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/21/2026

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: 240264428
• 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: 07/31/2024
• Initial Report FDA Received Date: 09/22/2026
• 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