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

Lot Number NGD2130

Device Problem Suction Problem (2170)

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

Event Type  malfunction  

Event Description

The plunger on the irrigation syringe would not hold suction.Fda safety report id # (b)(4).

• Brand Name: PISTON IRRIGATION TRAY
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 9871664
• MDR Text Key: 184886667
• Report Number: MW5093899
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2020

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 Expiration Date: 11/30/2022
• Device Lot Number: NGD2130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1