MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. 1LYRTR 16FR10ML 100%SILI SNAP; FOLEY CATHETER KIT (EXCLUDES HIV TESTING)

Model Number	URO175716
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Foley was inserted, inflated balloon with about 1.5ml when it stopped.Unable to insert or withdraw any fluid from the balloon.

• Brand Name: 1LYRTR 16FR10ML 100%SILI SNAP
• Common Device Name: FOLEY CATHETER KIT (EXCLUDES HIV TESTING)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 20576819
• Report Number: 20576819
• Device Sequence Number: 8170469
• Product Code: PPB
• UDI-Device Identifier: 10193489987423
• UDI-Public: (01)10193489987423
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/14/2024
• Report Date (Section F): 10/14/2024

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 Model Number: URO175716
• Device Catalogue Number: URO175716
• Device Lot Number: 24DBA665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Date Report Sent to FDA: 10/14/2024