MAUDE Adverse Event Report: ANGIODYNAMICS, INC ANGIOVAC CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Lot Number 5679882

Device Problems Positioning Failure (1158); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2021

Event Type  malfunction  

Event Description

The tuohy insert defected.The cannula would not go through the valve.

• Brand Name: ANGIOVAC CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS, INC; 8 glens falls technical park; glens falls NY 12801
• MDR Report Key: 12975252
• MDR Text Key: 282055313
• Report Number: 12975252
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/05/2021

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 Lot Number: 5679882
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male