MAUDE Adverse Event Report: CARDINAL HEALTH FOLY CATH 100 SLCON 5CC 14FR; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	8887605148
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: there is an issue with product #8887605148 purchased on po# (b)(4) for our ste-foy location account # (b)(6).Our client has been using foley¿s for a long time and they are always installed by the clsc and every time the clsc installed the foley¿s from that box, the foley balloon would be popped by the next day.They went through 4 foleys before having to switch to a different brand.Per additional information provided on 2/12/2024, the four instances or the balloon burst occurred with the same patient in less than 24 hours.The balloon was inflated with 5ml of liquid and ruptured with no fragmented pieces.The lubricant that was used was the mrx85-3001.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Ten brand new samples were received for evaluation.A visual and functional inspection was performed, and no failure was found.A root cause cannot be established since the reported issue could not be confirmed related to manufacturing/production process.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: FOLY CATH 100 SLCON 5CC 14FR
• 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; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18943833
• Report Number: 9611018-2024-00013
• Device Sequence Number: 8405510
• Product Code: FCM
• UDI-Device Identifier: 10884521016668
• UDI-Public: 10884521016668
• 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,Consumer,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 8887605148
• Device Catalogue Number: 8887605148
• Device Lot Number: 2305507
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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