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

Catalog Number ENCFF02

Device Problems Contamination (1120); Device Difficult to Setup or Prepare (1487); Failure to Prime (1492); Self-Activation or Keying (1557)

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

Event Date 05/02/2023

Event Type  malfunction  

Event Description

It was reported that prior to a biopsy procedure, the lever to prime the device allegedly cannot move.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a dhr 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.One photo was provided by the customer.First photo ¿image.Jpeg¿, shows that the label of the encor fire forward having the address details of senorx and serial number of the device.The serial number matches the serial number in the complaint.No other anomalies were noted on the device shown.Based on the photo review, the investigation is unconfirmed for reported lever to prime the device cannot move issue.The encor fire forward was visually inspected upon receipt and was found to be in bad overall condition and does not function.Also, found that the fire forward cover was missing, the cover and base were scratched, and both the pierce and safety switches were stuck.The serial label was at old revision.The device was functionally tested and failed the tests due to contamination causing improper latching and sliding of the slide block plate assembly identified during evaluation, the lever to prime the device moved freely but the device did not engage/disengage when expected.Furthermore, the device failed the safety function test due to the safety buttons being stuck in the open (unlocked) position and not returning to center, the device failed the pierce button function test due to the pierce button being intermittently stuck needing to be manually reset to move forward with testing, the driver bracket assembly experienced substantial resistance when being attached to the device due to contamination, the cocking handle moved freely but only intermittently engaged the internal latching and unintentional firing of the device was experienced during latch testing identified during evaluation.The device failed all testing except the firing travel test.Upon disassembly, it was confirmed that the device was heavily contaminated with blood and a white crusty substance.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported lever to prime the device cannot move issue, the investigation is determined to be confirmed for the identified safety buttons being stuck issue, the investigation is determined to be confirmed for the identified driver bracket assembly experienced substantial resistance issue, the investigation is determined to be confirmed for the identified pierce button being intermittently stuck issue and the investigation is determined to be confirmed for the identified unintentional firing issue.Based on the sample evaluation, the root cause for the reported lever to prime the device cannot move issue was determined to be due to contamination causing improper latching and sliding of the slide block plate assembly identified during evaluation.The root cause for identified safety buttons being stuck issue is unknown.The root cause for the identified driver bracket assembly experienced substantial resistance issue was determined to be due to contamination identified during evaluation.The root cause for identified pierce button being intermittently stuck issue is unknown.The root cause for identified unintentional firing 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: 12/2040).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.H3 other text: see h10.

• 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: 17753890
• MDR Text Key: 323493814
• Report Number: 2020394-2023-00689
• 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
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCFF02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• 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