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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 777426
Device Problem Accessory Incompatible (1004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2023
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 after insertion of the guide wire during operation, the ureteral stent could not be advanced smoothly.It was stated that the surgeon made several attempts and the problem occurred.The problem was addressed ultimately after the stent was replaced with a new one.
 
Event Description
It was reported that after insertion of the guide wire during operation, the ureteral stent could not be advanced smoothly.It was stated that the surgeon made several attempts and the problem occurred.The problem was addressed ultimately after the stent was replaced with a new one.
 
Manufacturer Narrative
The reported event is unconfirmed.Functional evaluation when the stent was removed from the package it could be seen that a guidewire had tried to be inserted into the sample.The guidewire was removed, and a new 0.035" guidewire passed through the sample without hesitation.The two guidewires provided with the sample were measured as 0.038".A 0.038" guidewire would not be able to pass through the sample.The guidewires that are provided with the sample would not be provided by biomerics.The device history record review was not required as the reported event was unconfirmed.The labeling review was not required as the reported event was unconfirmed.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.H3 other text : the actual/suspected device was inspected.
 
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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 Key17405507
MDR Text Key320609666
Report Number1018233-2023-05543
Device Sequence Number1
Product Code FAD
UDI-Device Identifier10801741014489
UDI-Public(01)10801741014489
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 11/03/2023
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 Number777426
Device Lot NumberNGGW1535
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/10/2023
Initial Date FDA Received07/27/2023
Supplement Dates Manufacturer Received11/03/2023
Supplement Dates FDA Received11/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2022
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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