MAUDE Adverse Event Report: CARDINAL HEALTH FOLY CATH 100 SLCON 5CC 18FR; CATHETER, RETENTION TYPE, BALLOON

Model Number	8887605189
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the catheter's balloon broke and the catheter fell out.The catheter had to be changed 4 or 5 times over the period of one or two months due to this.The exact quantity and event dates are not known.No injury was reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: FOLY CATH 100 SLCON 5CC 18FR
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17393918
• Report Number: 9611018-2023-00604
• Device Sequence Number: 7657805
• Product Code: EZL
• UDI-Device Identifier: 20884521016702
• UDI-Public: 20884521016702
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/31/2023

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: 8887605189
• Device Catalogue Number: 8887605189
• Device Lot Number: 22L167FHX
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown