MAUDE Adverse Event Report: C. R. BARD, INC. ECONOMY PISTON IRRIGATION TRAY 70 CC SYRINGE; SYRINGE, IRRIGATING (NON DENTAL)

Lot Number NGEPO800

Device Problem Leak/Splash (1354)

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

Event Date 05/29/2020

Event Type  malfunction  

Event Description

Three issues where fluid leaked from piston syringe when fluid is pulled back into syringe.Will only hold approximately 50cc of volume.If pulled beyond 55cc, fluid will leak out.

• Brand Name: ECONOMY PISTON IRRIGATION TRAY 70 CC SYRINGE
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10152845
• MDR Text Key: 195100155
• Report Number: 10152845
• 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: 06/01/2020

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
• Device Operator: Health Professional
• Device Lot Number: NGEPO800
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1