MAUDE Adverse Event Report: Cardinal Health 200, LLC Dover; Catheter, Urological

Model Number	1619
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction

• Brand Name: Dover
• Common Device Name: Catheter, Urological
• Manufacturer (Section D): Cardinal Health 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): Cardinal Health; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; +1(508)618-3640
• MDR Report Key: 50503253
• Report Number: 1423537-2026-00274
• Device Sequence Number: 15974506
• Product Code: KOD
• UDI-Device Identifier: 10192253026153
• UDI-Public: (01)10192253026153(17)310206(10)6037U13QX
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K860484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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 Model Number: 1619
• Device Catalogue Number: 1619
• Device Lot Number: 6037U13QX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown