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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIMENSION® STONE BASKET

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C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIMENSION® STONE BASKET Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921); Mechanical Jam (2983)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2018
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. The device was not returned.
 
Event Description
It was reported that the basket did not close completely. The urologist was performing a flexible ureteroscopy. During capture of the calculus, the dimension basket did not close completely which prevented it from being safely removed from the patient. There was a delay in the procedure and additional surgical time to remove the basket. The doctor was able to fragment it and remove it safely from the patient.
 
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Brand NameBARD® DIMENSION® 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 Key7539288
MDR Text Key109238995
Report Number1018233-2018-01838
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/23/2020
Device Model NumberN/A
Device Catalogue Number042310
Device Lot NumberBMZBM032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2015
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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