MAUDE Adverse Event Report: CARDINAL HEALTH FOLY CATH 100 SLCON 5CC 16FR; BAG, HEMOSTATIC

Model Number 8887605163

Device Problem Unintended Deflation (4061)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the balloon ruptures 3-4 days after catheter insertion.Per additional information received, there weren't any pieces missing.The volume of liquid used to inflate the balloon was 5ml.The lubricant used was the one from the catheterization tray code 85-5037.The catheter was removed from the patient by the nurse at home.There was no medical intervention required.

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.A corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.

• Brand Name: FOLY CATH 100 SLCON 5CC 16FR
• Type of Device: BAG, HEMOSTATIC
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HELATH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18960431
• MDR Text Key: 338432043
• Report Number: 1282497-2024-00505
• Device Sequence Number: 1
• Product Code: FCB
• UDI-Device Identifier: 10884521016675
• UDI-Public: 10884521016675
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8887605163
• Device Catalogue Number: 8887605163
• Device Lot Number: 2224845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1