MAUDE Adverse Event Report: STERIGEAR, LLC STERIGEAR URINARY DRAIN BAG; FIG LEAF DRAIN BAG

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/25/2017

Event Type  malfunction  

Event Description

Collection chamber locked and not draining into indwelling catheter bag (negative pressure valve stuck and non - return valve closed.) removed when pt admit to icu.Dates of use: (b)(6) 2017.

• Brand Name: STERIGEAR URINARY DRAIN BAG
• Type of Device: FIG LEAF DRAIN BAG
• Manufacturer (Section D): STERIGEAR, LLC; provo UT
• MDR Report Key: 6653104
• MDR Text Key: 78034111
• Report Number: MW5070513
• Device Sequence Number: 1
• Product Code: FCN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 50