MAUDE Adverse Event Report: CARDINAL HEALTH 3560 KENGUARD SILCATH 5CC 16FR; CATHETER, UROLOGICAL

Model Number	3560
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
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 there was a hole in the balloon.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed because the lot number was not available.No sample was received for the evaluation.The complaint will be reopened if the sample is received.The exact root cause could not be determined.The reported condition could not be confirmed.No action plan is needed at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 3560 KENGUARD SILCATH 5CC 16FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 19034102
• Report Number: 9611712-2024-00003
• Device Sequence Number: 18151730
• Product Code: KOD
• UDI-Device Identifier: 10192253026344
• UDI-Public: 10192253026344
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: 3560
• Device Catalogue Number: 3560
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/22/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown