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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD SKYLITE TIPLESS NITINOL STONE BASKET SKYLITE BASKET

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C.R. BARD, INC. (COVINGTON) -1018233 BARD SKYLITE TIPLESS NITINOL STONE BASKET SKYLITE BASKET Back to Search Results
Model Number 041900
Device Problem Material Fragmentation (1261)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 01/26/2021
Event Type  Injury  
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 skylite basket was coming off. Per follow up with ibc via mail on 22dec2020, the equipment was used on a patient, when the basket was closed after having located the calculus, it was impossible to close it, and it got stuck. The device had to be pulled very hard, even torn off, and one end came off, to migrate. User took a second basket to recover the piece detached but same scenario happened when closing it (same lot). Fine biopsy forceps had to be used to retrieve the piece from the basket.
 
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Brand NameBARD SKYLITE TIPLESS NITINOL STONE BASKET
Type of DeviceSKYLITE BASKET
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 Key11349023
MDR Text Key232577194
Report Number1018233-2021-00661
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model Number041900
Device Catalogue Number041900
Device Lot NumberNGDS2253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2019
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: 02/19/2021 Patient Sequence Number: 1
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