MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TRAY FOL TEMP UM 16FR 10ML MF

Catalog Number	DYND150816TS
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Update to a2, a3a, a4, b3, b5, and h6: after further investigation, it has been determined that the patient is a 72-year-old male weighing 229 pounds.The incident occurred on 01/06/2026.According to the facility on 01/06/2026, after a foley catheter was inserted, the balloon was inflated with sterile water and the syringe was disconnected.Fluid was noted at the urethral opening coming out around the catheter, and upon retraction of the catheter, it completely came out.A second attempt was made using a new foley kit and the same issue occurred.A third attempt was made using a new foley kit, and no problems were reported.The original two foley balloons were tested and were shown to be leaking.The patient was discharged home.The health impact code has been updated to additional device required, and the medical device problem code has been updated to device dislodgement and leaking.The investigation involved historical data analysis and review of production records; the device was not returned.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on 01/06/2026, after a foley catheter was inserted, the balloon was inflated with sterile water and the syringe was disconnected.Fluid was noticed at the urethral opening coming out around the catheter, and upon retraction of the catheter it completely came out.A second attempt was made using a new foley kit and the same issue occurred.A third attempt was made using a new foley kit and no problems were reported.The original two foley balloons were tested and were shown to be leaking.The patient was discharged home.
Event or Problem Description
According to the facility, two foley catheters with tears in the balloon were involved, and both catheters were inserted into a patient before the balloon defect was identified.
Additional Manufacturer Narrative
According to the facility, two foley catheters with tears in the balloon were involved, and both catheters were inserted into a patient before the balloon defect was identified.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: TRAY FOL TEMP UM 16FR 10ML MF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24223320
• Report Number: 1417592-2026-00075
• Device Sequence Number: 20884460
• Product Code: OHR
• UDI-Device Identifier: 10195327149871
• UDI-Public: 10195327149871
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: DYND150816TS
• Device Lot Number: 25ABW570
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 104 KG