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

Model Number	788726
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The ureteral stent, pusher and pigtail straightener were returned, the stent was returned in the opened original packaging.All measurements were found to be within specifications.A potential root cause for this event could be, "inappropriate package design".It is unknown if the device was used, however, it is intended for treatment purposes.As the device was observed to be damage, it appears to have contributed to the reported event.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: "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." "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." the actual/suspected device was evaluated.
Event or Problem Description
It was reported that the catheter was found to be broken and the coil separated with the straight site after opening the package.It was stated that the user used another new inlay.Per notification from investigator on 08nov2021, it was reported that the returned stent sample was found with different lot number.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14363761
• Report Number: 1018233-2022-03629
• Device Sequence Number: 4921894
• Product Code: FAD
• UDI-Device Identifier: 00801741015847
• UDI-Public: (01)00801741015847
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2022

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: 01/10/2024
• Device Model Number: 788726
• Device Catalogue Number: 788726
• Device Lot Number: NGDY1801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2019
• 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