MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DOVER; CATHETER, RETENTION TYPE, BALLOON

Model Number	1518C
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that on 26 december 2024, a 18 fr red tieman latex catheter was installed and on (b)(6) 2025 pierced balloon was observed.A new16 fr yellow tieman latex catheter has been re-installed.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot 3345u73qx was reviewed and no anomalies related to the reported issue were observed.A device was received for evaluation and the reported condition was observed; however, 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, RETENTION TYPE, BALLOON
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH 200, LLC; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21178365
• Report Number: 1423537-2025-00037
• Device Sequence Number: 4300059
• Product Code: EZL
• UDI-Device Identifier: 10192253027440
• UDI-Public: (01)10192253027440(17)281208(10)3345U73QX
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K990500
• 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): 02/19/2025

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: 1518C
• Device Catalogue Number: 1518C
• Device Lot Number: 3345U73QX
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/19/2025
• 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