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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT Back to Search Results
Catalog Number 788426
Device Problem Material Fragmentation (1261)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/23/2023
Event Type  malfunction  
Event Description
It was reported that the stent broke after opening the sterile package and removing the ureteral stent from the sealed bag.The event increased the operation time of health care professional and replace it with a new stent, which increased the cost of the department.There was a delay in surgery.
 
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.
 
Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted the sample was provided with the original bard inlay pouch inside a large ziploc bag.Also received 2 photo samples.First photo sample shows stent and push catheter within open packaging.Second photo sample shows packaging label in native language.Dimensional evaluation noted dimensional requirements per (b)(4) state the od is to be 0.061 ± 0.002", tip id to be 0.039" ± 0.002", guidewire to be 0.035" ± 0.001", and tube id to be 0.040" +0.002" -0.001".The sample passed all dimensional requirements per (b)(4).The od measured at 0.0619" and 0.0617" using a laser micrometer.The tip id was measured using a 0.039" ping gauge.The tube id was measured using a 0.040" pin gauge.A 0.035" guidewire passed through the sample with no hesitation.The root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be user does not handle with care, bends sharply.However, there was insufficient information to confirm this potential root cause.The dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and states the following: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." "the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." 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 stent broke after opening the sterile package and removing the ureteral stent from the sealed bag.The event increased the operation time of health care professional and replace it with a new stent, which increased the cost of the department.There was a delay in surgery.
 
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Brand Name
BARD® INLAY OPTIMA® URETERAL STENT
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 Key18309779
MDR Text Key330274777
Report Number1018233-2023-08868
Device Sequence Number1
Product Code FAD
UDI-Device Identifier00801741015687
UDI-Public(01)00801741015687
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K043193
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 04/08/2024
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 Number788426
Device Lot NumberNGGX4128
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received04/08/2024
Supplement Dates FDA Received04/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2022
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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