MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR FIRE FORWARD; BIOPSY EQUIPMENT

Catalog Number	ENCFF02
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.The device has been returned to the manufacturer for evaluation.As the serial number for the device was provided, a review of the device history records is currently being performed.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during preparation for a stereotactic breast biopsy, the fire forward allegedly fired without selecting the trigger.There was no patient contact.

• Brand Name: ENCOR FIRE FORWARD
• Common Device Name: BIOPSY EQUIPMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6330772
• Report Number: 2020394-2017-00072
• Device Sequence Number: 10976089
• Product Code: KNW
• UDI-Device Identifier: 00801741086458
• UDI-Public: (01)00801741086458(17)401231
• Combination Product (Y/N): N
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: ENCFF02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1