MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; CATHETER CARE TRAY

Model Number URO170816T

Device Problems Break (1069); Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2020

Event Type  malfunction  

Event Description

Nurse attached water syringe to the balloon port of the foley catheter, the tip of the syringe snapped off inside the hub, rendering the foley catheter unusable.Foley kit had to be replaced.Nursing also noted that if the water syringe is not pushed in hard enough, it has a tendency to slip out of the port.If pushed on too hard, tip of syringe breaks.

• Brand Name: MEDLINE
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 10655590
• MDR Text Key: 210613260
• Report Number: 10655590
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URO170816T
• Device Catalogue Number: URO170816T
• Device Lot Number: 20EBS824
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2020
• Event Location: Other
• Date Report to Manufacturer: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1