MAUDE Adverse Event Report: CARDINAL HEALTH 1621G LTX CATH 5CC 2-WAY 20FR; CATHETER, UROLOGICAL

Model Number	1621
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the balloon came out on the day of the catheter placement.The same event occurred two times on the same patient.Prior to indwelling, it was confirmed that the balloon had no leakage when water was poured, so it has been pointed out that the issue can be derived by the patient; period of use: less than a day.There was no harm to the patient involved.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Please disregard this report number 9611712-2024-00002, as upon further confirmation received from the customer, the issue reported was not against the cardinal health product 1621g ltx cath 5cc 2-way 20fr.The issue was inadvertently reported to cardinal health.

• Brand Name: 1621G LTX CATH 5CC 2-WAY 20FR
• 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: 18951586
• Report Number: 9611712-2024-00002
• Device Sequence Number: 12533741
• Product Code: KOD
• UDI-Device Identifier: 10192253026160
• UDI-Public: 10192253026160
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: 1621
• Device Catalogue Number: 1621
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/02/2024
• 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