MAUDE Adverse Event Report: C.R. BARD, INC. BARD PISTON IRRIGATION TRAY; SYRINGE, IRRIGATING

Catalog Number 750307

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2020

Event Type  malfunction  

Event Description

During bladder irrigations, staff unable to irrigate with normal saline.Device plunger leaks and not holding normal saline.Multiple irrigation trays with same issue.No patient harm.

• Brand Name: BARD PISTON IRRIGATION TRAY
• Type of Device: SYRINGE, IRRIGATING
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9933728
• MDR Text Key: 186772191
• Report Number: 9933728
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 750307
• Device Lot Number: NGDY2131
• 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: 04/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1