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

Model Number DYND11802

Device Problems Collapse (1099); Inability to Irrigate (1337); Product Quality Problem (1506); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

The issues with these catheters are they are cheap and flimsy, and fluid does not run into the inflow port, nor can the regular port be irrigated due to collapsing of the rubber of the catheter.Today, 45 minutes of time was wasted troubleshooting this catheter in the operating room while the patient was asleep.Previously i have had to exchange these catheters in the pacu when they were clogged and unable to be irrigated.

• Brand Name: MEDLINE
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 14052280
• MDR Text Key: 288869587
• Report Number: 14052280
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2022,03/01/2022

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: Other
• Device Model Number: DYND11802
• Device Catalogue Number: DYND11802
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Male
• Patient Race: White