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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 NITINOL BASKET

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C.R. BARD, INC. (COVINGTON) -1018233 BARD SKYLITE TIPLESS NITINOL STONE BASKET NITINOL BASKET Back to Search Results
Model Number 041900
Device Problems Material Fragmentation (1261); Material Protrusion/Extrusion (2979)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2020
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 piece of skylite 1. 9fr nitinol basket was flecked off.
 
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Brand NameBARD SKYLITE TIPLESS NITINOL STONE BASKET
Type of DeviceNITINOL 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 Key10919727
MDR Text Key218723052
Report Number1018233-2020-21245
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number041900
Device Catalogue Number041900
Device Lot NumberNGER4644
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2020
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: 11/30/2020 Patient Sequence Number: 1
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