MAUDE Adverse Event Report: ICU MEDICAL, INC. LEVEL 1 FOLEY CATHETERS; CATHETER, UROLOGICAL

Catalog Number	FC400-14
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Pain (1994); Genital Bleeding (4507)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the patient was having a catheter exchange due to inability to have urine return from bph.Nurse colleague attempted to irrigate foley catheter but unable to withdraw.Withdrew 6ml from balloon and started to pull, patient was visibly uncomfortable and squirming in bed, when foley was removed the balloon remained partly inflated, another 4ml emptied from catheter balloon.Trauma to penis, mild bleeding after procedure.Temp foley that was removed had balloon size of 5ml, 10 ml in total removed.Unable to completely deflate balloon while in patient bladder despite multiple attempts to ensure all fluid removed.Level of the harm was minimal.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H2) device evaluation: d3 manufacturer establishment name updated.H3, h6: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.

• Brand Name: LEVEL 1 FOLEY CATHETERS
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): ICU MEDICAL, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21124661
• Report Number: 3012307300-2025-00552
• Device Sequence Number: 12682573
• Product Code: KOD
• UDI-Device Identifier: 10695085000495
• UDI-Public: (01)10695085000495(17)260505(20)1103706
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K873448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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 Catalogue Number: FC400-14
• Device Lot Number: 1103706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown