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

Model Number	ENCFINSERT10G
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.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.
Event or Problem Description
It was reported that after completing a stereotactic-guided biopsy, when needle was removed, allegedly a plastic piece was found in the needle guide.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was completed, which identified that this is the first complaint record for this lot number.Labeling review: the review of the ifu (instruction for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Investigation summary: one encor needle guide insert was received for evaluation.The encor needle guide insert was received with the alleged foreign material sealed within a tyvek package.No visual anomalies were noted to the needle guide insert.The needle guide was visually inspected thoroughly and no visual anomalies were noted.Additionally, the received material was examined via ftir spectroscopy and unable to provide results of the material composition due to the minimal amount of material returned within the sealed tyvek package.Therefore, the investigation is inconclusive for the reported foreign material issue as the received material could not be identified and it is unknown where it came from.Per the ftir spectra analysis was unable to provide results due to the minimal amount of material received within the sealed tyvek package.Per the photo review, it is unknown what the object or material composition is or where it came from.Additionally, it was reported by the ibc that "the foreign material found in the device may have melted during their contamination process." therefore, a definitive root cause for the reported foreign material or material composition could not be determined based upon the provided information.H11:section a through f - the information provided by bard 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 bard.
Event or Problem Description
It was reported that after completing a stereotactic-guided biopsy, when needle was removed, allegedly a plastic piece was found in the needle guide.There was no reported patient injury.

• Brand Name: ENCOR BIOPSY DEVICE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8053036
• Report Number: 2020394-2018-01998
• Device Sequence Number: 1472871
• Product Code: KNW
• UDI-Device Identifier: 00801741086465
• UDI-Public: (01)00801741086465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040842
• 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): 04/06/2020

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: ENCFINSERT10G
• Device Catalogue Number: ENCFINSERT10G
• Device Lot Number: VTBW0378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1