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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

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C.R. BARD, INC. (COVINGTON) -1018233 BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET Back to Search Results
Model Number 041900
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 tip of the stone basket broke off inside the patient. The complainant reported that the broken tip was retrieved using another stone basket.
 
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Brand NameBARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET
Type of DeviceSTONE BASKET
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key9353623
MDR Text Key179260475
Report Number1018233-2019-07459
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00801741111518
UDI-Public(01)00801741111518
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,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model Number041900
Device Catalogue Number041900
Device Lot NumberNGDR0399
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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