MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DOVER; CATHETER, UROLOGICAL

Model Number	1619
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
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 they took out the product from the freshly opened package, and checked the product if the balloon would inflate by injecting the 10 ml of sterilized water using a syringe.The customer was able to inject the water, and the balloon inflated without problems.However, when pulling the syringe to remove the water, it has only removed about 5 ml, and the balloon did not deflate.By repeating the syringe pulling process a few times, the water was removed eventually.There was no patient use; period of use: unknown.
Additional Manufacturer Narrative
Section d4: lot number and unique identifier (udi) # has been updated.
Additional Manufacturer Narrative
The device history record (dhr) for lot 4148u13qx was reviewed and no anomalies related to the reported issue were observed.A device was received for evaluation and the reported condition was not observed.A definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.We will continue to track and trend through our monitoring programs and take actions as applicable.

• Brand Name: DOVER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH, INC.; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20860349
• Report Number: 1423537-2024-00333
• Device Sequence Number: 11776839
• Product Code: KOD
• UDI-Device Identifier: 10192253026153
• UDI-Public: (01)10192253026153(17)290524(10)4148U13QX
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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: 1619
• Device Catalogue Number: 1619
• Device Lot Number: 4148U13QX
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 12/12/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown