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

Model Number 0038460

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2021

Event Type  malfunction  

Event Description

Syringe failed to retain fluid inside syringe during surgical procedure.

• Brand Name: TOOMEY SYRINGE
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11357603
• MDR Text Key: 232806295
• Report Number: 11357603
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0038460
• Device Catalogue Number: 0038460
• Device Lot Number: NGDZ4063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA