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

Catalog Number	ENCFF02
Medical Device Problem Codes	Self-Activation or Keying (1557); Component Missing (2306); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot 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.H10: d4 (expiry date: 12/2040).H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device pending return.
Event or Problem Description
It was reported that during a biopsy procedure, the fire forward allegedly only shoots from one side.It was further reported that the device allegedly fires without depressing safety and trigger.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 encor fire forward was received for evaluation.The encor fire forward was visually inspected upon receipt and was found to be in good overall condition and does not function to specification.Furthermore, the device was cocked and found fire forward cover was missing with the unit.The cover was found to be scratched.The device was functionally tested and failed the tests as safety buttons did not slide between the locked and unlocked position.Instead, the buttons were sticking, not returning to center (locked position) as expected due to contamination within the pierce lockout plate and the associated hardware causing safety buttons were stuck to one side, disabling the safety feature of the device.Furthermore, there was intermittent difficulty in firing, caused by the lack of lubrication on the mating surfaces of the latching hardware.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported fire forward only shoots from one side and the investigation is determined to be confirmed for the identified fire forward cover was missing, and the investigation is determined to be confirmed for the identified difficulty in firing issue.The root cause for reported fire forward only shoots from one side issue was determined to be significant contamination within the pierce lockout plate and the associated hardware causing the buttons to stick identified during evaluation.The root cause for identified difficulty in firing issue was determined to be lack of lubrication on the mating surfaces of the latching hardware identified during evaluation.The root cause for identified cover was missing issue is unknown.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.H10: d4 (expiry date: 12/2040), g3, h6 (device).H11: section a through f ¿ the information provided by bd represents all 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 prior to a biopsy procedure, the fire forward allegedly only shoots from one side.It was further reported that the device allegedly fires without depressing safety and trigger.There was no patient contact.

• 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: 18247913
• Report Number: 2020394-2023-01127
• Device Sequence Number: 12407900
• Product Code: KNW
• UDI-Device Identifier: 00801741086458
• UDI-Public: (01)00801741086458
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/21/2023
• 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