MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIOPSY PROBE 10G; BIOPSY INSTRUMENT

Model Number ECP0110G

Device Problems Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

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

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 09/2021).

Event Description

It was reported that prior to a breast biopsy procedure, the device allegedly had an abnormal sound.It was further reported that foreign material was found on the device.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one encor biopsy probe and vacuum assembly were returned for evaluation.During visual evaluation, the biopsy probe appeared to be clean and the aperture was received completely closed.Foreign material was noted on the device.Upon functional testing, the probe was loaded into the driver and calibrated successfully.The probe was calibrated an additional two times, both times were successful.No unusual noises were heard.Upon microscopic observation, the device was examined further under the microscope and residue was found to be on the aperture and cutter of the probe.Therefore, the investigation is confirmed for the reported foreign material issue as the foreign material was noted on the device.A definitive root cause for the reported foreign material issue could not be determined based upon the provided information.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: (expiry date: 09/2021).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.

Event Description

It was reported that prior to a breast biopsy procedure, the device needle allegedly had foreign material.It was further reported that no abnormal noises from the probe were heard.There was no patient contact.

• Brand Name: ENCOR BIOPSY PROBE 10G
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12532461
• MDR Text Key: 273330454
• Report Number: 2020394-2021-01805
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086243
• UDI-Public: (01)00801741086243
• Combination Product (y/n): N
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ECP0110G
• Device Catalogue Number: ECP0110G
• Device Lot Number: VTDW0638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1