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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2021
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 the patient underwent flexible right ureteroscopy and an analysis on the stone sampling was needed. One of the stone basket was unpacked and was found broken.
 
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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 Key11598312
MDR Text Key243311542
Report Number1018233-2021-01749
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeCH
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 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number041900
Device Catalogue Number041900
Device Lot NumberNGER0447
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2020
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: 03/31/2021 Patient Sequence Number: 1
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