MAUDE Adverse Event Report: C. R. BARD, INC. BARDIA® PISTON IRRIGATION TRAY; SYRINGE, IRRIGATING (NON DENTAL)

Model Number 802060

Device Problem Filling Problem (1233)

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

Event Date 02/26/2020

Event Type  malfunction  

Event Description

Staff report multiple (at least 5) instances over the last month of the 70cc syringe in the irrigation tray does not hold water.Plunger is not water-tight.When fluid drawn up into syringe - fluid drains out if not held upright.

• Brand Name: BARDIA® PISTON IRRIGATION TRAY
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9915548
• MDR Text Key: 186160119
• Report Number: 9915548
• Device Sequence Number: 1
• Product Code: KYZ
• 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: 03/19/2020,03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802060
• Device Catalogue Number: 802060
• Device Lot Number: NGDY0252
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2020
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1