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

Model Number PK7644959

Device Problem Leak/Splash (1354)

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

Event Date 04/13/2020

Event Type  malfunction  

Event Description

While syringe was used by rn, when drawing up ns, syringe leaks.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: 10194434
• MDR Text Key: 196429858
• Report Number: 10194434
• 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: 05/28/2020

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 Model Number: PK7644959
• 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: 05/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA