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

Model Number	MQ1820
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that post prostate biopsy, the patient developed a hematoma after the procedure.The current patient status is unknown.
Event or Problem Description
It was reported that post prostate biopsy, the patient developed a hematoma after the procedure.The current patient status is unknown.
Additional Manufacturer Narrative
After further review of this complaint on (b)(6) 2019 noted that the no additional information was received on if any intervention was taken as no additional information was received.Therefore, the complaint will be malfunction.As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

• Brand Name: BARD MARQUEE DISPOSABLE CORE BIOPSY INSTRUMENT KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8592048
• Report Number: 2020394-2019-00556
• Device Sequence Number: 19406780
• Product Code: KNW
• UDI-Device Identifier: 00801741097218
• UDI-Public: (01)00801741097218
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MQ1820
• Device Catalogue Number: MQ1820
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/17/2019
• 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: Required Intervention