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

Model Number DBAG600

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2021

Event Type  malfunction  

Event 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
• Type of Device: BAG, BILE COLLECTING
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 11847650
• MDR Text Key: 251368502
• Report Number: 11847650
• Device Sequence Number: 1
• Product Code: EXF
• 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: 05/05/2021,02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DBAG600
• Device Catalogue Number: DBAG600
• Device Lot Number: 11329915
• 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: 05/05/2021
• Date Report to Manufacturer: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA