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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 BARD FLATWIRE STONE BASKETS

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C.R. BARD, INC. (COVINGTON) -1018233 BARD PLATINUM CLASS II FLAT WIRE STONE BASKET BARD FLATWIRE STONE BASKETS Back to Search Results
Model Number 039690
Device Problems Material Fragmentation (1261); Misassembly by Users (3133)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2020
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 one dormia probe was broken when the box was opened and basket rod not attached to the handle. For the second probe, the rod had detached from the handle after a single use and without even forcing it. Both were from the same lot.
 
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Brand NameBARD PLATINUM CLASS II FLAT WIRE STONE BASKET
Type of DeviceBARD FLATWIRE STONE BASKETS
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key10740381
MDR Text Key213198630
Report Number1018233-2020-20453
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2022
Device Model Number039690
Device Catalogue Number045290
Device Lot NumberBMBUMM01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/27/2020 Patient Sequence Number: 1
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