MAUDE Adverse Event Report: CARDINAL HEALTH FOLY CATH 100 SLCON 5CC 16FR; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	8887605163
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation because the device was discarded.
Event or Problem Description
Customer reports: two of the catheters are busted.Per additional information received on 03/15/24, the catheter was inside the patient for 6 days before the balloon burst.
Additional Manufacturer Narrative
The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One picture was provided by the customer.By examining the picture, the balloon of the catheter is visibly broken.Since the physical sample was not provided the root cause and corrective actions could not be identified.If a sample is received in the future, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: FOLY CATH 100 SLCON 5CC 16FR
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18944391
• Report Number: 1282497-2024-00503
• Device Sequence Number: 14167752
• Product Code: FCM
• UDI-Device Identifier: 20884521016672
• UDI-Public: 20884521016672
• Combination Product (Y/N): N
• 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): 05/29/2024

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: 8887605163
• Device Catalogue Number: 8887605163
• Device Lot Number: 2324204
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/29/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown