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 Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2020

Event Type  malfunction  

Event Description

Continued concerns with salem neobladders and piston leaks fluid when rn draws up ns for irrigation.There appears to be an issue with the plunger, it does not have a seal.It does not hold fluid when held in the dependant position.It leaks out ns quickly without pressure on the plunger.This is a recurring problem.Multiple reports have been submitted to the manufacturer and product has returned.The problem continues and is unresolved.

• Brand Name: BARD PISTON IRRIGATION TRAY
• Type of Device: SYRINGE, IRRIGATING
• Manufacturer (Section D): C.R. BARD INC; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 10194431
• MDR Text Key: 196429757
• Report Number: 10194431
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 750307
• Device Lot Number: NGEQ1853
• 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: 06/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA