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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 045315
Device Problems Mechanical Problem (1384); Device Inoperable (1663)
Patient Problems No Patient Involvement (2645); 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 information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the stone basket would not close, so it was not used.
 
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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
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7480366
MDR Text Key107332970
Report Number1018233-2018-01428
Device Sequence Number1
Product Code FFL
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 company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number045315
Device Catalogue Number045315
Device Lot NumberBMCNMM01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2018
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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