MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE

Model Number	786426
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ureteral stent was found to be ruptured upon opening the package.It was mentioned that four quantities were affected.Per follow up information received via ibc on 02nov2022, it was stated that only one stent was affected.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The ureteral stent was returned in the opened original packaging.An evaluation of the photo sample was completed by futurematrix.Although a specific cause cannot be determined, a potential root cause for this event could be, "inappropriate package design".No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and state 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 the inner polybag to eliminate tearing or fragmentation." correction: d,g h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the ureteral stent was found to be ruptured upon opening the package.It was mentioned that four quantities were affected.Per follow up information received via ibc on 02nov2022, it was stated that only one stent was affected.There was no impact to the patient.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
• Common Device Name: 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 Key: 15741326
• Report Number: 1018233-2022-08441
• Device Sequence Number: 6203320
• Product Code: FAD
• UDI-Device Identifier: 10801741015042
• UDI-Public: (01)10801741015042
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2024
• Device Model Number: 786426
• Device Catalogue Number: 786426
• Device Lot Number: NGFU2656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 11/06/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown