MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; CATHETER, RETENTION TYPE, BALLOON

Model Number DYND11760

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2021

Event Type  malfunction  

Event Description

There have been a few accounts of medline silicone-elastomer coated latex catheters dysfunctions.Patient underwent robotic prostatectomy.Patient was discharged home with silastic foley catheter.Patient presented to emergency dept two and a half weeks post op, after catheter balloon malfunctioned and catheter "slipped out." patient required foley catheter replacement via cystoscopy in the ed.

• Brand Name: MEDLINE
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 11663607
• MDR Text Key: 245333982
• Report Number: 11663607
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10080196726547
• UDI-Public: (01)10080196726547
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2021

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: No Information
• Device Model Number: DYND11760
• Device Catalogue Number: DYND11760
• Device Lot Number: (10)59220122557
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2021
• Date Report to Manufacturer: 04/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1