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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAGNUM NEEDLE BIOPSY INSTRUMENT

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BARD PERIPHERAL VASCULAR, INC. MAGNUM NEEDLE BIOPSY INSTRUMENT Back to Search Results
Model Number MN1410
Device Problems Device Markings/Labelling Problem (2911); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records 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. Device not returned.
 
Event Description
It was reported that during a stereotactic guided breast biopsy procedure through normal density tissue, the needle allegedly bent. A coaxial needle was not used and the procedure was completed using another device. There was no reported patient injury.
 
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Brand NameMAGNUM NEEDLE
Type of DeviceBIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13123301
MDR Text Key283089883
Report Number2020394-2021-02133
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K934370
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMN1410
Device Catalogue NumberMN1410
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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