MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MAGNUM DISPOSABLE BY NEEDLE; BIOPSY NEEDLE 18GX20CM

Model Number MN1820

Device Problem Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2019

Event Type  malfunction  

Event Description

The dr did a prostate biopsy on 07/10/2019.On the 12th core, we did not get a specimen, we tried twice more and on the last one.As the dr tried to unload the core, small pieces of pink plastic fell out of the device.We replaced the needle and finished the exam.This issue happened again on (b)(6) 2019 except on the first try, this also happened the 3rd week in (b)(6) with three needles.We sent pictures of the needles to bard on these three.It also happened in (b)(6) and i kept that needle and sent it to bard.After talking to our bard rep, we did get 4 replacement needles, but no explanation of the problem.This problem subjects the pt to add'l biopsies which increase the risk of infection to the pt.

• Brand Name: BARD MAGNUM DISPOSABLE BY NEEDLE
• Type of Device: BIOPSY NEEDLE 18GX20CM
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; 1625 west 3rd st. ; tempe AZ 85281
• MDR Report Key: 8879243
• MDR Text Key: 154315483
• Report Number: MW5088908
• Device Sequence Number: 4
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MN1820
• Device Catalogue Number: MN1820
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 81