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	11/06/2020
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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 09/2021).
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy, the device allegedly had a contamination of a foreign material within the sample tray upon retrieving the sample.There was no reported patient injury.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy, the device allegedly had a contamination of a foreign material within the sample tray upon retrieving the sample.There was no reported patient injury.
Additional 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 was returned for evaluation.The probe appeared to be bloody with the aperture closed.The saline cap was returned.The protective tubing was removed from the needle with resistance.Foreign material was returned and taped to a piece of paper.Scathing was noted to the inside of the protective tubing.The proximal retaining cap was glued to the probe.No damage was noted to the rear housing.No other anomalies were identified.Upon microscopic examination, foreign material was not found to be on the aperture and cutter of the probe.Therefore, the investigation is confirmed for the reported foreign material, as foreign material was retuned in a piece of paper.A definitive root cause for the reported failure could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 09/2021).H11: section a through f ¿ 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.H3 other text : see h10.

• 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: 10964257
• Report Number: 2020394-2020-20769
• Device Sequence Number: 16778910
• 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): 12/10/2020

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: VTDW0658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 04/23/2021
• 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