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

Model Number URO170716

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2016

Event Type  malfunction  

Event Description

Medline foley emptied at 350ml.About 70 minutes later, during assessment, pt with complains of having a full bladder.Bladder palpated and noted to be full.Dependent drain bag noted to have 200 ml in the bag with urine in the tubing.After manipulating the foley numerous times, 700ml of urine were drained from bladder with patient having relief.

• 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: 6020258
• MDR Text Key: 57203804
• Report Number: 6020258
• 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: Other
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: URO170716
• Device Catalogue Number: URO170716
• 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: 09/13/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR