MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN COVIDIEN 24 FR, 5 CC FOLEY CATHETER; CATHETER, RETENTION TYPE BALLOON

Model Number 3570

Device Problems Obstruction of Flow (2423); Defective Device (2588)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 05/22/2019

Event Type  Injury  

Event Description

Suprapublic foley catheter was inserted on (b)(6) 2019.It stopped draining on the evening of (b)(6) 2019 at the pt's home.The pt's blood pressure (bp) was elevated (as high as "203/110").Nitro paste was applied and bp was monitored until a new catheter could be inserted (1.5 hours later).Bladder drained and pt's bp returned to normal.The defective catheter was saved and found to be blocked near the top (completely blocked with balloon inflated, 7 cc; mostly blocked with balloon deflated).(b)(6).

• Brand Name: COVIDIEN 24 FR, 5 CC FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE BALLOON
• Manufacturer (Section D): MEDTRONIC / COVIDIEN ; minneapolis MN
• MDR Report Key: 8764195
• MDR Text Key: 150361754
• Report Number: MW5087893
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2023
• Device Model Number: 3570
• Device Catalogue Number: 3570
• Device Lot Number: 8335K16QX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2019
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 61