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

Model Number MQ1410

Device Problems Mechanical Problem (1384); Failure to Obtain Sample (2533); Activation Problem (4042)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/23/2023

Event Type  malfunction  

Event Description

Upon deploying the biopsy device, the "snap" was very weak resulting in push back from the tissue instead of taking a clean sample through it.Used 12ga bard marquee with ease.

• Brand Name: BARD MARQUEE 14GA BIOPSY DEVICE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st; tempe AZ 85281
• MDR Report Key: 17331868
• MDR Text Key: 319117270
• Report Number: 17331868
• 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: 06/23/2023

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 Model Number: MQ1410
• Device Catalogue Number: MQ1410
• Device Lot Number: 0001501092
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2023
• Event Location: Other
• Date Report to Manufacturer: 07/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1