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

Lot Number 0165SI16

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

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

Event Date 05/17/2021

Event Type  malfunction  

Event Description

Pt felt a "pop" sensation and alerted rn.Rn found foley sliding out of patient with balloon ruptured.All pieces appear accounted for.Pt bladder was irrigated during c/s.Formula found in foley bag after balloon rupture.Catheter used appropriately, inserted to proper depth, no harm to patient, no known retention of foley.Fda safety report id# (b)(4).

• Brand Name: FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): BARD / C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 12086020
• MDR Text Key: 259145408
• Report Number: MW5102177
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2021

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 Lot Number: 0165SI16
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2021
• 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: 30 YR