MAUDE Adverse Event Report: CARDINAL HEALTH DOVER SILICONE CNCL 24FR5CC2W; CATHETER, UROLOGICAL

Model Number	40524L
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that a foley catheter was being used in their birthing center and the balloon burst and had to be removed from the patient.
Additional Manufacturer Narrative
The product was originally reported as product number (b)(4).However based on the physical sample returned and photographs, the device is not product (b)(4).The correct product number was not able to be determined.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending pu.

• Brand Name: DOVER SILICONE CNCL 24FR5CC2W
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 19212913
• Report Number: 1282497-2024-00510
• Device Sequence Number: 20568396
• Product Code: KOD
• UDI-Device Identifier: 10884521019881
• UDI-Public: 10884521019881
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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
• Device Model Number: 40524L
• Device Catalogue Number: 40524L
• Device Lot Number: 8180229
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown