MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. DRAINAGE BAG 600ML; BAG, BILE COLLECTING

Model Number	DBAG600
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Faulty supplies (argon medical device, drainage bag 600ml, attaches to nephrostomy tubes or drainage tubes, lot #11329915, ref# dbag600).The nursing staff use these frequently, and have noticed many times that the blue cap on the bottom does not properly twist or lock into place.It then leaks urine out from the end for the patient during their daily life and activities.They have to tape it shut and it gets sticky, difficult to use, and messy.

• Brand Name: DRAINAGE BAG 600ML
• Common Device Name: BAG, BILE COLLECTING
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 11847650
• Report Number: 11847650
• Device Sequence Number: 16756923
• Product Code: EXF
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/09/2021
• Report Date (Section F): 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: DBAG600
• Device Catalogue Number: DBAG600
• Device Lot Number: 11329915
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/05/2021