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

Model Number	121410
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 number was provided for each of the malfunctions.For the three reported malfunctions, the devices have been returned to bd for evaluation.The company is still investigating the issue at this time.The devices are labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model 121410 biopsy instrument allegedly experienced failure to obtain sample and difficult to remove.This information was received from a single source.Each malfunction involved a patient with no known impact to the patient.The patients' age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for each of the malfunctions, therefore lot history reviews were performed.For the three reported malfunctions, one device was returned for evaluation.The investigation for the returned sample is unconfirmed for failure to obtain samples and difficult to remove.The investigation is inconclusive for the two samples that were not returned.The definitive root cause could not be determined based upon available information.The devices are labeled for single use.H10: g4, h6 (method : 4111).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 three malfunctions.A review of the reported information indicated that model 121410 biopsy instrument allegedly experienced failure to obtain sample and difficult to remove.This information was received from a single source.Each malfunction involved a patient with no known impact to the patient.The patients' age, weight, and gender were not provided.

• 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: 9944293
• Report Number: 2020394-2020-02573
• Device Sequence Number: 13619635
• Product Code: KNW
• UDI-Device Identifier: 00801741084584
• UDI-Public: (01)00801741084584
• 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): 06/24/2020

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: 121410
• Device Catalogue Number: 121410
• Device Lot Number: REDU0533
• 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: 06/24/2020
• Patient Sequence Number: 1