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

Catalog Number 750307

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/20/2020

Event Type  malfunction  

Event Description

During use of the bard irrigation tray, the syringe from the tray would not hold normal saline.Syringe was leaking.This is a recurring problem at this facility.The manufacturer has been notified and product has been returned.The problem is still happening.More than one lot is involved.Multiple reports have been submitted.

• Brand Name: BARD 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: 10061008
• MDR Text Key: 191107632
• Report Number: 10061008
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• 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: NGDY2130
• 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: 05/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA