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

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	10/02/2020
Type of Reportable Event	Malfunction
Additional 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 and the evaluation is still pending.The investigation of the reported event is currently underway.(expiry date: 08/2021).
Event or Problem Description
It was reported prior to a breast biopsy, the device allegedly had a foreign material.There was no patient contact.
Event or Problem Description
It was reported prior to a breast biopsy procedure, the device allegedly had a foreign material.There was no patient contact.
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 has returned for evaluation.On the visual evaluation of the probe, it appeared clean and the aperture closed partially.Foreign material appeared on the tip of the aperture and scratching has noted inside the protective tube.The proximal retaining cap has glued to the probe and no damage has noted to the rear housing.No other anomalies noted to the probe.Functional evaluation has not performed due to the nature of the complaint.Microscopic observation also confirms the foreign material on the aperture and cutter of the probe.Therefore, the reported foreign material is confirmed as the plastic fragment noted at the tip of the aperture.A definitive root cause could not be determined.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.D4: (expiry date: 08/2021).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.

• Brand Name: ENCOR BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10754526
• Report Number: 2020394-2020-20293
• Device Sequence Number: 11705410
• Product Code: KNW
• UDI-Device Identifier: 00801741086267
• UDI-Public: (01)00801741086267
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: VTDV0581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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