MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; FOLEY TRAY NS SILI 14FR

Catalog Number	DYND11NS14S
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "all cs of (b)(6) being unusable because the blue drape is visible thus the sterile field is broken.".
Additional Manufacturer Narrative
The customer reported all cs of the foley tray being unusable because the blue drape is visible thus the sterile field is broken.The investigation stated this was an intentional change made to the configuration of the 2 layer tray and that the layout of the components in the 2 layer foley catheter insertion trays will be changing.The reported sterile field broken condition was not confirmed; the investigation stated the whole tray inside the packaging goes through sterilization and it is still sterile even though it is not completely covered by the csr wrap.The investigation concluded this is not a qa issue, the customer has been notified of the change, and the complaint will be closed as customer knowledge.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: FOLEY TRAY NS SILI 14FR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50802563
• Report Number: 1417592-2026-43325
• Device Sequence Number: 10610483
• Product Code: OHR
• UDI-Device Identifier: 40888277085795
• UDI-Public: 40888277085795
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/15/2026

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: DYND11NS14S
• Device Lot Number: 23EBW737
• 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: 09/29/2023
• Initial Report FDA Received Date: 09/17/2026
• 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