MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD BIOPSY MARQUEE 14GA; INSTRUMENT, BIOPSY

Model Number MQ1410

Device Problems Defective Device (2588); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

When the attending radiologist was advancing the device, the tip bent in the tissue on two patients.This is not appropriate in this setting.We opened a different ga needle for the first patient, however upon the second patient we realized it was devices in the same lot number and successfully used a different lot number device.Three total devices were bent.Defective device lot #: 0001494129.

• Brand Name: BARD BIOPSY MARQUEE 14GA
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st.; tempe AZ 85281
• MDR Report Key: 16426510
• MDR Text Key: 310092560
• Report Number: 16426510
• Device Sequence Number: 1
• Product Code: KNW
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MQ1410
• Device Catalogue Number: MQ1410
• Device Lot Number: 0001494129
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1