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

Model Number P4P16CSDK

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 318113036
• Report Number: 9612030-2023-03741
• Device Sequence Number: 1
• Product Code: FCN
• UDI-Device Identifier: 10884521174061
• UDI-Public: 10884521174061
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• 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
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1