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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 Problem Wrong Label (4073)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/17/2023
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 customer opened the package during the operation and found that the stent catheter was 426 model, but the push tube was 626, which could not be matched for normal use.
 
Event Description
It was reported that the customer opened the package during the operation and found that the stent catheter was 426 model, but the push tube was 626, which could not be matched for normal use.
 
Manufacturer Narrative
The reported event is inconclusive as the original packaging was not returned.Visual evaluation noted received 1 stent with no original packaging.Returned size of stent is 4.7 f x 26 cm.As original packaging was not returned the reported event cannot be confirmed.Although an exact root cause could not be determined a potential root cause could be incorrect line clearance.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review is not required as the labelling would not have prevented the reported event.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
GUIDEWIRE
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 Key18099931
MDR Text Key328499462
Report Number1018233-2023-07974
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 01/18/2024
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 Number786426
Device Lot NumberNGGV5149
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/17/2023
Initial Date FDA Received11/09/2023
Supplement Dates Manufacturer Received01/19/2024
Supplement Dates FDA Received01/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2022
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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