MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

Model Number	121610
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 121610 biopsy instrument allegedly had a black foreign material.There was no reported patient involvement.This information was received from one source.
Additional Manufacturer Narrative
H10: one device was returned for evaluation.The lot history review was performed.Black foreign material was identified inside of the clear tubing with the gauze.A root cause has not been determined.The device is labeled for single use.H10: g4 (pma/510k).H11: g1 (mfr site), h6 (results, conclusion).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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 121610 biopsy instrument allegedly had a black foreign material.There was no reported patient involvement.This information was received from one source.

• Brand Name: MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8783212
• Report Number: 2020394-2019-01478
• Device Sequence Number: 2014477
• Product Code: KNW
• UDI-Device Identifier: 00801741084607
• UDI-Public: (01)00801741084607
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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: No Information
• Device Model Number: 121610
• Device Catalogue Number: 121610
• Device Lot Number: RECV4046
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1