MAUDE Adverse Event Report: CARDINAL HEALTH P400 UM 16FR SIL COUDE CSD IFC; URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER

Model Number	P4P16CSDK
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation because it was contaminated and therefore discarded.
Event or Problem Description
Customer reports: the foley balloon burst.Per additional information received on (b)(6)2023, the balloon bursts occurred with the same patient.Five hours after the 4th foley was replaced, the balloon popped again.Patient went to akron bath they put in an 18f foley which popped an hour later.She then returned to medina.Urology thought it could be related to a bladder stone.
Additional Manufacturer Narrative
We have concluded our investigation process related to your complaint.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 purposes.

• Brand Name: P400 UM 16FR SIL COUDE CSD IFC
• Common Device Name: URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17212678
• Report Number: 9612030-2023-03741
• Device Sequence Number: 6249226
• Product Code: FCN
• UDI-Device Identifier: 10884521174061
• UDI-Public: 10884521174061
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/23/2023

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: P4P16CSDK
• Device Catalogue Number: P4P16CSDK
• Device Lot Number: 2304400464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown