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

Model Number	121616
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 121616 monopty allegedly experienced self-activation.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided, therefore a lot history review was performed.The sample was returned to the manufacturer for evaluation.The investigation reported issue was unconfirmed for the reported self-activation.The definitive root cause is unknown.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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 121616 biopsy instrument allegedly experienced self-activation.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.

• Brand Name: MONOPTY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10266797
• Report Number: 2020394-2020-04395
• Device Sequence Number: 2329557
• Product Code: KNW
• UDI-Device Identifier: 00801741084614
• UDI-Public: (01)00801741084614
• 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): 07/13/2020

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: 121616
• Device Catalogue Number: 121616
• Device Lot Number: RECX1932
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 07/13/2020
• Patient Sequence Number: 1