MAUDE Adverse Event Report: BARD BARD ALL-SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 165816

Device Problem Physical Resistance (2578)

Patient Problem No Information (3190)

Event Date 06/13/2017

Event Type  malfunction  

Event Description

Cuff noted on catheter after foley removed.Both staff and patient noted there was resistance during removal process.No bleeding.We have experienced a total of 7 similar events to date.Two of the catheters are being returned to bard this week for evaluation.Dates of use: (b)(6) 2017.Diagnosis or reason for use: placed during surgery.Is the product compounded: no.Is the product over-the counter: no.

• Brand Name: BARD ALL-SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): BARD
• MDR Report Key: 6710647
• MDR Text Key: 80119180
• Report Number: MW5070970
• 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: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• 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: NGBP2622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 75 YR