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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. MAGNUM 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 11/28/2021
Event Type  malfunction  
Event Description
It was reported that during a biopsy procedure, the length of the needle was allegedly not accurate from label. It was further reported that needle was bent. There was no reported patient injury.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed. The device has not been returned to the manufacturer for evaluation. However, a photos were provided for review. The investigation of the reported event is currently underway. Expiry date: 09/2023.
 
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Brand NameMAGNUM
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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13070819
MDR Text Key282782515
Report Number2020394-2021-02099
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
Report Date 02/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMN1410
Device Catalogue NumberMN1410
Device Lot NumberREEX0619
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2020
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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