MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ONE LAYER SELECTSILICONE FOLEY CATHETER TRAY; CATHETER CARE TRAY

Catalog Number DYND160714

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

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

Event Date 01/06/2016

Event Type  malfunction  

Event Description

When removing the syringe after balloon inflation, the valve became separated and stayed attached to the syringe.

• Brand Name: ONE LAYER SELECTSILICONE FOLEY CATHETER TRAY
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1170 northpoint blvd.; park city IL 60085
• MDR Report Key: 6089471
• MDR Text Key: 59513839
• Report Number: 6089471
• 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: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/06/2016,09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: DYND160714
• Device Lot Number: 15GB0553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2016
• Event Location: Other
• Date Report to Manufacturer: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1