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

Model Number	121820
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot for the malfunctions were provided and a lot history review will be performed.The original sample and one lot sample were returned for evaluation.The investigation is currently underway.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the malfunctions indicated that model 121820 biopsy instrument allegedly experienced difficult to remove and failure to obtain sample.The report was received from a single source.The malfunctions involved a patient with no reported consequences.The 71 year old male patient's weight was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the malfunction indicated that model 121820 biopsy instrument allegedly experienced difficult to remove and failure to obtain sample.The report was received from a single source.The malfunction involved a patient with no reported consequences.The 71 year old male patient's weight was not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The original sample and one lot sample were returned for evaluation.Based on the sample evaluation,the investigation is unconfirmed for failure to obtain samples,however, the investigation is inconclusive for the reported difficult to remove.A definitive root cause has not been determined.The device is labeled for single use.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: BARD 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: 9944297
• Report Number: 2020394-2020-02574
• Device Sequence Number: 666083
• Product Code: KNW
• UDI-Device Identifier: 00801741084652
• UDI-Public: (01)00801741084652
• 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): 06/25/2020

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: No Information
• Device Model Number: 121820
• Device Catalogue Number: 121820
• Device Lot Number: REDV2266
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 06/25/2020
• Patient Sequence Number: 1