MAUDE Adverse Event Report: FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Foley catheter placed into patient's bladder under normal sterile technique.The foley was placed normally into the bladder with the foley advanced all the way to the hub and with good urine return noted before balloon was inflated.When balloon was inflated it was filled with normal amount of sterile water that comes with the kit in a pre filled syringe.When inflated the balloon burst and the foley came out.A second foley catheter was then placed since the first foley balloon burst.With the second foley the exact same scenario took place with the subsequent same result.Dr.Then attempted to place a 16fr non temp sensing foley and a 14fr coude with no urine return and no foley placed.A urology consult was placed for post procedure.Fda safety report id# (b)(4).

• Brand Name: FOLEY CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• MDR Report Key: 15371085
• Report Number: MW5111886
• Device Sequence Number: 14926302
• Product Code: OHR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown