MAUDE Adverse Event Report: C. R. BARD, INC. BARD FOLEY CATHETER TRAY; CATHETER, RETENTION TYPE, BALLOON

Model Number	897516
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The foley catheter balloon would not deflate when attempting to remove it from the patient.Multiple attempts were made to deflate the balloon without success.Urology was consulted and had to attempt to deflate the balloon but met with resistance each time.Finally, on 3rd attempt, they were able to release the balloon.Fda safety report id# (b)(4).

• Brand Name: BARD FOLEY CATHETER TRAY
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 10413155
• Report Number: MW5096083
• Device Sequence Number: 3190438
• Product Code: EZL
• UDI-Device Identifier: 00801741025020
• UDI-Public: (01)00801741025020(17)221031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 897516
• Device Catalogue Number: 897516
• Device Lot Number: NGEP0883
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other