MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CATHETER,URETH,VINYL,UNIVERSAL,16",14 FR

Catalog Number	DYND10723H
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that (b)(4) came in damaged and it looks like a sealing issue.
Additional Manufacturer Narrative
The customer reported that (b)(4) came in damaged and it looks like a sealing issue.Medline quality received (b)(4) of the reported product in packaged, unused condition, and visual assessment of the provided product revealed that a long cut on the pouch was present, running along the packaging lengthwise; the catheter was exposed, and the sterile barrier was compromised.The reported issue of damaged packaging was verified by visual assessment of the provided sample, but the root cause could not be determined; the vendor completed the investigation form, and a review of their records, manufacturing records, and retained samples found no abnormalities or defects.There are currently no known trends for this product, and medline quality will continue to monitor for the issue through monthly complaint meetings and quarterly trending analysis.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,URETH,VINYL,UNIVERSAL,16",14 FR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50755302
• Report Number: 1417592-2026-39396
• Device Sequence Number: 21172546
• Product Code: EZD
• UDI-Device Identifier: 10080196846825
• UDI-Public: 10080196846825
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/10/2026

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: DYND10723H
• Device Lot Number: 0332501A090
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/26/2025
• 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: 09/23/2025
• Initial Report FDA Received Date: 09/14/2026
• 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