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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 MN1820
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Needle Stick/Puncture (2462)
Event Type  Injury  
Manufacturer Narrative
The lot number was provided so a review of the device history records was performed. The sample was not returned to bd for 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 device is labeled for single use. (expiry date 08/2021).
 
Event Description
It was reported that during a prostate biopsy procedure, the user allegedly experienced a needle stick. It was further reported that the procedure was completed with another device. There were no further reported complications.
 
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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.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX 88780
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9732838
MDR Text Key180180080
Report Number2020394-2020-01084
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K934370
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMN1820
Device Catalogue NumberMN1820
Device Lot NumberREDX1626
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
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

Patient Treatment Data
Date Received: 02/20/2020 Patient Sequence Number: 1
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