MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; FOLEY CATHETER KIT (EXCLUDES HIV TESTING)

Model Number	URO175816
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Discomfort (2330)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple complaints: 1.The nurse was taking out the catheter.The nurse noted that only 9ml of sterile water was able to be pulled back in the syringe.The catheter was then cut and removed from the patient.2.Connected a sterile syringe to the balloon port and allowed 9.5ml to naturally backflow into the syringe.Then pulled back with the syringe to double-check if there was any more air or water left in the balloon.Pulled back 2 additional times to verify there was nothing left in the balloon.Catheter pulled out with no resistance.When it was completely out, there was still a tiny amount of air inflated in the balloon.Pt bled from his urethra for a few minutes afterwards and then resolved.3.Removing the patient's catheter- withdrew all 10ml of saline, got a second syringe, and double-checked that i removed it all, then pulled it.Upon removal, there was still a small amount of saline and/or air left, causing discomfort to the patient and ultimately a small amount of bleeding from the urethra.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: FOLEY CATHETER KIT (EXCLUDES HIV TESTING)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 25080737
• Report Number: 25080737
• Device Sequence Number: 10689048
• Product Code: PPB
• UDI-Device Identifier: 10193489987461
• UDI-Public: (01)10193489987461
• 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): 04/22/2026
• Report Date (Section F): 04/22/2026

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 Model Number: URO175816
• Device Catalogue Number: URO175816
• Device Lot Number: MULTIPLE -UNK
• 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: 05/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/22/2026