MAUDE Adverse Event Report: CARDINAL HEALTH CATH FOLEY SIL ELSTMR 5CC 16FR; CATHETER, UROLOGICAL

Model Number	402716
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Health effect - clinical code: 4581 (appropriate term / code not available) - used for minor trauma to the urethra.
Event or Problem Description
The customer reported that the balloons in this lot obstruct the catheter once inflated and it occurred on several occasions that they had a lot of difficulty deflating the balloon.On one occasion the balloon did not deflate and they had to remove the catheter with the balloon partially deflated causing trauma to a patient's urethra.Per additional information received, the patient had minor trauma to the urethra as the balloon could not be deflated and it was eventually removed with about 2ml still in the balloon, which is minor.The recovery was almost immediate.
Additional Manufacturer Narrative
Samples were received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual and functional evaluation of the sample, the reported issue was not confirmed; they were able to deflated as per normal function.However, a photo sample was received and upon visual evaluation, the reported issue was confirmed; it showed a flat wall condition which could have caused the difficulty deflating.A root cause analysis indicated that this occurred during the manufacturing process.Actions have been taken to address the reported condition.A quality alert was also issued to emphasize the importance of monitoring the reported issue.

• Brand Name: CATH FOLEY SIL ELSTMR 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: 18235129
• Report Number: 9611712-2023-00144
• Device Sequence Number: 16950192
• Product Code: KOD
• UDI-Device Identifier: 10884521016163
• UDI-Public: 10884521016163
• 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): 02/08/2024

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: 402716
• Device Catalogue Number: 402716
• Device Lot Number: 3081S12QX
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown