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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 Break (1069); Material Fragmentation (1261)
Patient Problems No Consequences Or Impact To Patient (2199); 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.
 
Event Description
It was reported that the distal portion of the protective sheath on a 3f platinum basket broken off of the basket during uncomplicated ureteroscopy for a distal stone and removed the foreign body using another basket.
 
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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 Key10253298
MDR Text Key198780324
Report Number1018233-2020-04427
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number045315
Device Catalogue Number045315
Device Lot NumberBMCRMM02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2018
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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