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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 Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
Patient Problems Foreign Body In Patient (2687); No Information (3190)
Event Date 06/20/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the doctor found what appeared to be a thread, attached on the distal tip of the basket during the fiber optic transurethral lithotripsy (f-tul) procedure. The doctor continued to use the device with the material attached. The surgery was completed without any problems. After surgery, the foreign material was not attached. The user requested to investigate if the foreign material like thread is from the sheath or basket.
 
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Brand NameBARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET
Type of DeviceBASKET
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 Key7681445
MDR Text Key113763767
Report Number1018233-2018-02743
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model Number041900
Device Catalogue Number041900
Device Lot NumberNGCN4498
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2018
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: 07/12/2018 Patient Sequence Number: 1
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