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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MONOPTY; BIOPSY INSTRUMENT
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BARD PERIPHERAL VASCULAR, INC. MONOPTY; BIOPSY INSTRUMENT Back to Search Results
Model Number 211610
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
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.However, the investigation is not identified for self-activation issue.The definitive root cause could not be determined based upon available information.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported malfunction indicated that model 211610 biopsy instrument allegedly experienced self-activation.This report was received from a single source.The malfunction was involved patient with no reported consequences.Age, weight, and gender of the patient was not provided.
 
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Brand Name
MONOPTY
Common Device Name
BIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10722869
Report Number2020394-2020-06004
Device Sequence Number13750999
Product Code KNW
UDI-Device Identifier00801741084713
UDI-Public(01)00801741084713
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/22/2020
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 Number211610
Device Catalogue Number211610
Device Lot NumberREDS2657
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2020
Initial Report FDA Received Date10/22/2020
Patient Sequence Number1
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