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

Model Number MN1616

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model mn1616 biopsy instrument experienced needle rust.This information was received from one source.This malfunction involved one patient with no patient consequences.The (b)(6) year old female patient was (b)(6) kgs.

Manufacturer Narrative

H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event 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 one malfunction.A review of the reported information indicated that model mn1616 biopsy instrument experienced needle rust.This information was received from one source.This malfunction involved one patient with no patient consequences.The 68 year old female patient was 53 kgs.

• Brand Name: MAGNUM NEEDLE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10280207
• MDR Text Key: 199062710
• Report Number: 2020394-2020-04468
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084300
• UDI-Public: (01)00801741084300
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MN1616
• Device Catalogue Number: MN1616
• Device Lot Number: REBU1002
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1