MAUDE Adverse Event Report: BARD FOLEY CATHETER; 16FRENCH 5CC

Lot Number NGAT 4144

Device Problem Deflation Problem (1149)

Patient Problems Pain (1994); Urinary Retention (2119); Injury (2348); Obstruction/Occlusion (2422)

Event Date 12/20/2016

Event Type  malfunction  

Event Description

Foley catheter balloon would not deflate properly.Withdrawn from person and balloon still retained 4cc saline which could not be removed with routine interventions.Pt experienced urethral pain and trauma with removal of balloon.Therapy dates: (b)(6) 2015 - (b)(6) 2016.Bph with outflow obstruction and urinary retention.

• Brand Name: FOLEY CATHETER
• Type of Device: 16FRENCH 5CC
• Manufacturer (Section D): BARD
• MDR Report Key: 6202088
• MDR Text Key: 63288980
• Report Number: MW5066879
• Device Sequence Number: 1
• Product Code: EZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2016

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: No Information
• Device Lot Number: NGAT 4144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 95 YR
• Patient Weight: 77