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

Model Number ENCFF02

Device Problems Contamination (1120); Unintended Movement (3026); Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2022

Event Type  malfunction  

Event Description

It was reported that during a breast biopsy procedure through scattered density tissue, the device allegedly misfired.There was no reported patient injury.

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 Description

It was reported that during a breast biopsy procedure through scattered density tissue, the device allegedly misfired.There was no reported patient injury.

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
• Type of Device: 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
• MDR Text Key: 298432585
• Report Number: 2020394-2022-00673
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086458
• UDI-Public: (01)00801741086458
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1