MAUDE Adverse Event Report: BARD MEDICAL / C. R. BARD, INC. FOLEY CATHETER INSERTION KIT; CATHETER, COUDE

Catalog Number A800361

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

Prior to insertion in a patient, foley catheter balloon was inflated.Upon attempts to deflate the balloon, the balloon would not deflate and remained inflated.Another foley kit was pulled and the balloon was inflated and would not deflate.No patient involvement, all events occurred prior to insertion to a patient.Ref report: mw5149211.

• Brand Name: FOLEY CATHETER INSERTION KIT
• Type of Device: CATHETER, COUDE
• Manufacturer (Section D): BARD MEDICAL / C. R. BARD, INC.; covington GA
• MDR Report Key: 18324414
• MDR Text Key: 330773176
• Report Number: MW5149212
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/11/2023

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 Operator: Health Professional
• Device Catalogue Number: A800361
• Device Lot Number: NGHU0295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1