MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DOVER; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	8887605148
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the catheter balloon was burst inside the patient and a chunk of the silicone remained in the patient¿s bladder.Additional information was received from the customer and stated that the foley was inserted on (b)(6) 2024, at 18:28 and the team noticed foley had come out at 19:15.The balloon was not intact.Per customer, cystoscopy procedure was performed to remove the fragments in the patient¿s bladder.The patient was discharged home on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2319843 was reviewed and no anomalies related to the reported issue were observed.The device was received for evaluation and the reported condition was observed; however, a definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.We will continue to track and trend through our monitoring programs and take actions as applicable.

• Brand Name: DOVER
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan MA 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20202573
• Report Number: 1423537-2024-00153
• Device Sequence Number: 15332918
• Product Code: FCM
• UDI-Device Identifier: 10884521016668
• UDI-Public: (01)10884521016668(17)280630(10)2319843
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K903340
• 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): 11/20/2024

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: 8887605148
• Device Catalogue Number: 8887605148
• Device Lot Number: 2319843
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/20/2024
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown