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

Model Number MN1825

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event for foreign material is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one(1) malfunction event.A review of the events indicated that model mn1825 biopsy instrument allegedly experienced foreign material in the sterile packaging.It was further reported the device was not opened and was discarded at the facility.This report was received from one source.This event did not involve a patient.

• Brand Name: MAGNUM CORE BIOPSY NEEDLES
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8520290
• MDR Text Key: 142202024
• Report Number: 2020394-2019-00351
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084362
• UDI-Public: (01)00801741084362
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MN1825
• Device Catalogue Number: MN1825
• Device Lot Number: RECV0025
• Date Manufacturer Received: 03/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1