MAUDE Adverse Event Report: CARDINAL HEALTH 6950 100 SILI FOLEY TY 18FR; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6950
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Sepsis (2067)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the balloon has busted and caused issues.Additional information received from the patient on (b)(6)2024 stated the catheter balloon deflated causing him to develop sepsis.This occurred around (b)(6) 2023.Exact date unknown.He was taken to the hospital via ambulance as he does not drive due to his multiple sclerosis diagnosis.He was admitted for about a week and was on an antibiotic.The name of the antibiotic is unknown.He stated the infection was related to the balloon deflating.He was told he is now more susceptible to infections.He stated he has been using the dover foleys for 5 years and did not have a problem until last year.He confirmed that he only uses the lubricant from the kit, no other products are used.
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 as no lot number or product samples were returned for evaluation.The manufacturing process was reviewed.The current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.The product 6950 was discontinued in august 2023.No actions are required at this time.All information received will be used for tracking and trending purposes.

• Brand Name: 6950 100 SILI FOLEY TY 18FR
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18610862
• Report Number: 9612030-2024-00031
• Device Sequence Number: 18003335
• Product Code: KNX
• UDI-Device Identifier: 20884521154299
• UDI-Public: 20884521154299
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6950
• Device Catalogue Number: 6950
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male