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

Model Number 0038460

Device Problems Leak/Splash (1354); Suction Problem (2170); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2020

Event Type  malfunction  

Event Description

Attempting to administer contrast via toomey syringe.The plunger of the toomey syringe was defective.Used 3 different syringes, each time the plunger would not hold suction and contents spilled out.

• Brand Name: TOOMEY SYRINGE
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): C. R. BARD, INC.; 1211 mary magnan blvd; madison GA 30650
• MDR Report Key: 10641347
• MDR Text Key: 210203466
• Report Number: 10641347
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• 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: NGEN1788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Date Report to Manufacturer: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA