MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIOPSY PROBE

Model Number	ECP0112G
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record 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 or Problem Description
It was reported that during a breast biopsy, foreign material allegedly found on the sample tray.There was no reported patient injury.
Additional Manufacturer Narrative
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.It was noted that a sample container with unknown fluid containing a piece of unknown material.During visual evaluation, the biopsy probe appeared to be bloody with the aperture completely closed.The saline cap was returned.Functional evaluation was not performed due to the nature of the complaint.Upon further microscopic evaluation, the piece of material that was received in the container of fluid was noted to be a translucent and curls were noted on both ends and flash was noted to the sample tray.Flash was noted to the port cap hole on the sample tray.Slight burrs were noted to the sample tray handle.Therefore, the investigation is confirmed for the reported foreign material issue on the sample container.Additional ftir analysis has been completed on the returned material to determine the material compound.Results indicate the material to be consistent with the sample tray basket material, polyethylene and the material also contained small amounts of silicone.Based upon the results of the ftir analysis, it was determined the material is consistent with the sample tray material.A definitive root cause for the foreign material could not be determined.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.The information provide 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 during a breast biopsy procedure, foreign material was allegedly found on the sample tray.There was no reported patient injury.

• Brand Name: ENCOR BIOPSY PROBE
• Common Device Name: ENCOR BIOPSY PROBE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11160547
• Report Number: 2020394-2020-21050
• Device Sequence Number: 3920622
• Product Code: KNW
• UDI-Device Identifier: 00801741086267
• UDI-Public: (01)00801741086267
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: ECP0112G
• Device Catalogue Number: ECP0112G
• Device Lot Number: VTDW0659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other