MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE FOLEY CATHETER UROLOGY KIT WITH DRAINAGE BAG; CATHETER CARE TRAY

Model Number 22CBY251

Device Problems Inflation Problem (1310); Material Rupture (1546); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2022

Event Type  malfunction  

Event Description

During insertion of medline 16 fr indwelling foley catheter i attempted to fill the balloon after urine output was reached with 10 ml of ns and when pulling the catheter to set in place, it slipped out of the patient.I noticed the balloon was not inflated and upon closer look, the balloon had ruptured.I quickly got another foley kit and attempted insertion again and filled the balloon with 10 ml of ns and it also ruptured.On the third attempt, i first checked the balloon prior to insertion and it was only able to be filled to 5.5ml without warping shape and looking like it would rupture, so i inserted it and was successful with inserting the balloon with only 5 ml of ns.Fda safety report id #(b)(4).

• Brand Name: MEDLINE FOLEY CATHETER UROLOGY KIT WITH DRAINAGE BAG
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 15192914
• MDR Text Key: 297686358
• Report Number: MW5111360
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• 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: 08/05/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 22CBY251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White