MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CATHETER,URETHRAL,VINYL,FEMALE,6",14FR

Catalog Number	DYND10703
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ends are not sealed shut so item is not sterile.
Additional Manufacturer Narrative
The complaint reported the product problem/issue of ends not sealed shut and that the item is not sterile.Medline quality received 3 cs total of the reported product, which was received in packaged, unused condition, and visual assessment of the provided product revealed that the packaging was not properly sealed on the end of the peel pouch.The reported issue of unsealed sterile packaging was verified by visual assessment of the provided samples, and the likely root cause was attributed to be a human error during the sealing process of the packaging.The manufacturing facility implemented additional training to personnel to avoid recurrence of the issue, and the remaining product from this lot was put on hold for further inspection.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: CATHETER,URETHRAL,VINYL,FEMALE,6",14FR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50843474
• Report Number: 1417592-2026-46733
• Device Sequence Number: 10270270
• Product Code: EZD
• UDI-Device Identifier: 40080196846741
• UDI-Public: 40080196846741
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K091306
• 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): 09/18/2026

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: DYND10703
• Device Lot Number: 0332309A162
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2024
• 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: 06/03/2024
• Initial Report FDA Received Date: 09/21/2026
• 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