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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE Back to Search Results
Catalog Number 777626
Device Problem Wrong Label (4073)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/08/2023
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.
 
Event Description
It was reported that the specifications and models were inconsistent with the ureteral stent tubes in the actual package.The actual stent tube was thin and could not be used with the supporting guidewire, which affects the progress of the operation and increases the cost of the operation.The surgery was delayed.
 
Manufacturer Narrative
The reported event is confirmed.Visual evaluation noted received 1 used and 4 unused ureteral stents with guidewires in original packaging.Upon unpacking samples it was found in all returned samples that the contained incorrect stent size of 4.7 fr x 26 cm was packaged.Also received 1 photo sample showing stent laying on top of packaging.Based on physical sample received product does not meet specifications.The root cause is product mix potentially occurred during an incorrectly segregated and returned material process in combination with a poorly performed line release.Labeling review, and dhr review are not required.Section a through f - the information provided by bd represents all 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 bd.
 
Event Description
It was reported that the specifications and models were inconsistent with the ureteral stent tubes in the actual package.The actual stent tube was thin and could not be used with the supporting guidewire, which affects the progress of the operation and increases the cost of the operation.The surgery was delayed.
 
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Brand Name
BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
Type of Device
URETERAL STENT
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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key18317377
MDR Text Key330363624
Report Number1018233-2023-08900
Device Sequence Number1
Product Code FAD
UDI-Device Identifier10801741014557
UDI-Public(01)10801741014557
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K983498
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number777626
Device Lot NumberNGGY3400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/22/2023
Initial Date FDA Received12/13/2023
Supplement Dates Manufacturer Received03/13/2024
Supplement Dates FDA Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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