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	No Clinical Signs, Symptoms or Conditions (4582)
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 the balloon obstructs the catheter once inflated and they had a lot of difficulty deflating the balloon.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that: one unused device from the reported lot number was received at the manufacturing site for 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 returned device, the reported issue was not confirmed; the device was able to deflate as per normal function.However, a photo was received and upon visual evaluation, the reported issue was confirmed; it showed a flat wall condition which caused the difficulty deflating.A root cause analysis indicated that this occurred during the manufacturing process.A quality alert was issued to the responsible personnel to emphasize the importance of monitoring for this issue.All information received will be used for further tracking and trending purposes.Update made to h6 type of investigation, investigation findings and investigation conclusions.
Additional Manufacturer Narrative
The product was released accomplishing all quality standards according to a review of the device history record.A representative sample which was unused/unopened was tested and no issues were found on the returned sample.A photo was also provided and review; the reported issue was confirmed from the photo.However, based on all available information, an exact root cause could not be determined.A quality alert will be issued to the responsible personnel to emphasize the importance of monitoring for this type of issue.No further actions are required at this time.All information received will be used for further tracking and trending purposes.

• 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: 18242433
• Report Number: 9611712-2023-00146
• Device Sequence Number: 6644790
• 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,Followup
• Report Date (Section B): 02/21/2024

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: 11/28/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 11/28/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/19/2024; 02/21/2024
• 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