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

Model Number	ENCFF02
Medical Device Problem Codes	Contamination (1120); Unintended Movement (3026); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a breast biopsy procedure through scattered density tissue, the device allegedly misfired.There was no reported patient injury.
Additional Manufacturer Narrative
As the serial number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiration date: 12/2099.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 or Problem Description
It was reported that during a breast biopsy procedure through scattered density tissue, the device allegedly misfired.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review and manufacturing review was not required as the event was determined to be expected and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the fire forward encor was returned for evaluation.The fire forward encor was visually inspected upon receipt and was found to be in good conditions and functions normally.The fire forward cover was missing and there were scratches present on the cover, during disassembly, there was blood along interior of the housing, screw points where the housing is attached to the base identified during evaluation.The device was functionally tested and passed the tests during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device misfiring and difficult to fire issue and the investigation is determined to be confirmed for the identified contamination issue.The root cause for the reported misfiring and difficult to fire issue cannot be determined as the problem could not be reproduced.The root cause for the identified contamination issue is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 12/2099), g3, h6 (device) h11: b3, e1, h6 (method, result, conclusion) 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.

• Brand Name: ENCOR FIRE FORWARD
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15256596
• Report Number: 2020394-2022-00673
• Device Sequence Number: 17810618
• Product Code: KNW
• UDI-Device Identifier: 00801741086458
• UDI-Public: (01)00801741086458
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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 Model Number: ENCFF02
• Device Catalogue Number: ENCFF02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown