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

Catalog Number	788624
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tail of ureteral stent was cut off while opening the package of ureteral stent.
Additional 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 or Problem Description
It was reported that the tail of ureteral stent was cut off while opening the package of ureteral stent.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted visual requirements states to "use unaided eye at 12" to 18" distance under normal room lighting unless otherwise noted." when evaluating the sample provided the separation could be located at the proximal pigtail.The separation appears to be cut due to no stretching or discoloration of the material.The complaint reports that the sample was cut during the opening of the package.The separation is due to mishandling of the product.Also received one photo sample which shows stent laying on top of product packaging with pigtail broken off.Based on photo and physical sample received product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be user does not handle with care, bends sharply.A dhr review did not show any problems or conditions that would have 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 inner polybag so as not to cause 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." 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.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18093599
• Report Number: 1018233-2023-07963
• Device Sequence Number: 6670359
• Product Code: FAD
• UDI-Device Identifier: 00801741015755
• UDI-Public: (01)00801741015755
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 788624
• Device Lot Number: NGGZ0166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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