MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC MEDLINE-INDWELLING URINARY CATHETER; CATHETER CARE TRAY

Lot Number 20IBH741

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2021

Event Type  malfunction  

Event Description

Nursing noticed leaking from patient's foley insertion area assuming it was urine.Day rn added saline amount of 2ml to balloon.Night rn still noticed leaking around the foley insertion area.Balloon inspected and identified only able to withdraw 6ml saline amount instead of normal 10ml.Foley replaced.

Event Description

Nursing noticed leaking from patient's foley insertion area assuming it was urine.Day rn added saline amount of 2ml to balloon.Night rn still noticed leaking around the foley insertion area.Balloon inspected and identified only able to withdraw 6ml saline amount instead of normal 10ml.Foley replaced.

• Brand Name: MEDLINE-INDWELLING URINARY CATHETER
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; one medline pl; mundelein IL 60060
• MDR Report Key: 11626920
• MDR Text Key: 244173802
• Report Number: 11626920
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 20IBH741
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Date Report to Manufacturer: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25185 DA