MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAGNUM CORE BIOPSY NEEDLE; BIOPSY INSTRUMENT

Model Number MN1820

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model mn1820 biopsy instrument experienced foreign material present in device.This report was received from one source.The event involved a patient with no reported patient injury.The patient¿s age, sex, and weight were not provided.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation; however, a photo of the reported event was received and reviewed.The investigation is inconclusive for foreign material.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model mn1820 biopsy instrument experienced foreign material present in device.This report was received from one source.The event involved a patient with no reported patient injury.The patient¿s age, sex, and weight were not provided.

• Brand Name: MAGNUM CORE BIOPSY NEEDLE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8491716
• MDR Text Key: 141204652
• Report Number: 2020394-2019-00250
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084355
• UDI-Public: (01)00801741084355
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• 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
• Device Lot Number: REBV2126
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1