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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 Problem Material Fragmentation (1261)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2021
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 skylite basket was broken when tried to remove a kidney stone from a patient during the ureteroscopy. No medical intervention was reported.
 
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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 Key12487679
MDR Text Key271881893
Report Number1018233-2021-05731
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 Other,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number041900
Device Catalogue Number041900
Device Lot NumberNGFT0635
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2021
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: 09/17/2021 Patient Sequence Number: 1
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