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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
Model Number 788626
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2022
Event Type  malfunction  
Event Description
It was reported that the doctor inspected the consumables and the ureteral stent prior to operation.Upon opening the case, the doctor found that the primary package had been opened.The event included extra operation or drug therapy.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.A potential root cause for this failure mode could be ¿product packaging obviously not sealed or torn, i.E.Out of box failure¿.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.A labeling review was not performed because labelling could not have prevented the reported failure.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.
 
Event Description
It was reported that the doctor inspected the consumables and the ureteral stent prior to operation.Upon opening the case, the doctor found that the primary package had been opened.The event included extra operation or drug therapy.Per follow-up information received from ibc on 11aug2022, stated that customer replaced a new device.No patient was involved cause the the event occurred before use.
 
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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 Key15232495
MDR Text Key297953800
Report Number1018233-2022-06412
Device Sequence Number1
Product Code FAD
UDI-Device Identifier00801741015762
UDI-Public(01)00801741015762
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 01/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number788626
Device Catalogue Number788626
Device Lot NumberNGFV2363
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/02/2022
Initial Date FDA Received08/16/2022
Supplement Dates Manufacturer Received01/31/2023
Supplement Dates FDA Received02/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2021
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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