MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR DRIVER; BIOPSY INSTRUMENT

Model Number ECP0110G

Device Problems Contamination (1120); Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

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 is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The device is labeled for single use.

Event Description

This report summarizes one(1) malfunction event.A review of the event indicated that model ecp0110g biopsy instrument allegedly experienced movement in an unintended rotational sequence.This report was received from one source.This event involved one patient whose gender, age and weight were not provided.This patient had no reported patient injury.

Manufacturer Narrative

Of the one device, the product catalog has been changed to (drencor), lot number is na and the serial number is (dyyhg018).The sample was not returned.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.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(1) malfunction.A review of the event indicated that model drencor biopsy instrument allegedly experienced movement in an unintended rotational sequence.This report was received from one source.This report was received from a single source.The patients age, weight and gender were not provided.

Manufacturer Narrative

H10: the reported device was returned to bd for evaluation.The investigation of the reported malfunction is confirmed for unintended movement and contamination during use.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for reuse.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 drencor biopsy instrument allegedly experienced unintended movement and contamination during use.This report was received from one source.The malfunction involved a patient with no reported patient injury.The patients age, weight and gender were not provided.

• Brand Name: ENCOR DRIVER
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8525186
• MDR Text Key: 142476787
• Report Number: 2020394-2019-00463
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086243
• UDI-Public: (01)00801741086243
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2020

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: No Information
• Device Model Number: ECP0110G
• Device Catalogue Number: DRENCOR
• Device Lot Number: VTCW0455
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 06/30/2019; 12/31/2019
• Supplement Dates FDA Received: 07/25/2019; 01/06/2020
• Patient Sequence Number: 1