MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYR 14FR10ML 100%SIL TMP TRAY

Catalog Number	DYND160814T
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "nurse attempted to deflate balloon and no saline came out.Nurse then squeezed tubing below syringe connected area and 8cc of saline came out.".
Additional Manufacturer Narrative
The customer reported that the nurse attempted to deflate the balloon and no saline came out, and the nurse then squeezed tubing below syringe connected area and 8cc of saline came out.Medline quality received 1 ea of the reported product in unpackaged, used condition; visual assessment revealed no defects nor abnormalities, measurement of the catheter balloon dimensions met the specified product criteria, and functional testing revealed no defects nor abnormalities.The reported issue of balloon deflation failure could not be verified based on visual or functional inspection of the received sample; it was noted that a normal saline syringe was attached to the inflation port when first received, and sterile water is recommended to inflate the foley balloon as normal saline can crystallize within the balloon/inflation lumen, which may cause deflation issues.Based on the sample evaluation and current trends, this complaint is unconfirmed.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: 1LYR 14FR10ML 100%SIL TMP TRAY
• 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: 50693352
• Report Number: 1417592-2026-34909
• Device Sequence Number: 9614766
• Product Code: OHR
• UDI-Device Identifier: 10884389123102
• UDI-Public: 10884389123102
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/04/2026

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: DYND160814T
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2025
• 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: 05/09/2025
• Initial Report FDA Received Date: 09/09/2026
• 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