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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 WITH NICORE¿ GUIDEWIRE
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE Back to Search Results
Catalog Number 786426
Device Problems Material Fragmentation (1261); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2023
Event Type  malfunction  
Event Description
It was reported that when the ureteral stent was being removed from the pigtail modulator after opening the package, breakage occurred with the stent.It was stated that the additionally, evident signs of crease were found at the stent tubing pigtail end.
 
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 when the ureteral stent was being removed from the pigtail modulator after opening the package, breakage occurred with the stent.It was stated that the additionally, evident signs of crease were found at the stent tubing pigtail end.
 
Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted received 2 photo samples.First photo sample shows top view of stent broken into 2 separate pieces with one pigtail end missing.Second photo sample zooms in on breakage point on stent.Therefore, product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be inappropriate package design.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "precautions: 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 the inner polybag to eliminate tearing or fragmentation." 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 OPTIMA® URETERAL STENT WITH NICORE¿ 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 Key17413083
MDR Text Key320509293
Report Number1018233-2023-05566
Device Sequence Number1
Product Code FAD
UDI-Device Identifier10801741015042
UDI-Public(01)10801741015042
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 12/27/2023
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 Number786426
Device Lot NumberNGGU2851
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/11/2023
Initial Date FDA Received07/28/2023
Supplement Dates Manufacturer Received12/27/2023
Supplement Dates FDA Received12/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2022
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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