MAUDE Adverse Event Report: BARD BARD ALL-SILICONE FOLEY CATHETER; URINARY CATHETER

Model Number 165816

Device Problem Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2017

Event Type  malfunction  

Event Description

Nurse reported he felt resistance when removing foley catheter.Once the catheter was removed, the nurse noticed that the balloon on the catheter had a cuff.Staff aware of bard's ifus for foley insertion removal.We had a total of 11 similar events now with this specific product.Dates of use: (b)(6) 2017.Diagnosis or reason for use: orthopedic surgery.

• Brand Name: BARD ALL-SILICONE FOLEY CATHETER
• Type of Device: URINARY CATHETER
• Manufacturer (Section D): BARD
• MDR Report Key: 6971149
• MDR Text Key: 90218781
• Report Number: MW5072891
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2017

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 Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGB93109
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR