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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET

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C.R. BARD, INC. (COVINGTON) -1018233 BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET Back to Search Results
Model Number 045390
Device Problems Failure to Capture (1081); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the product did not perform as intended, and did not result in successful stone retrieval every time they used it. The respondent stated they had to use different baskets a few times to retrieve stones.
 
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Brand NameBARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET
Type of DeviceSTONE BASKET
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key9413354
MDR Text Key178577382
Report Number1018233-2019-07709
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00801741066900
UDI-Public(01)00801741066900
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number045390
Device Catalogue Number045390
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
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

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