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

Model Number	786626
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when placing the ureteral stent on (b)(6) 2023, the director and professor inspected the outer package of the corresponding model and found no problem with it.Upon opening of the package, they found that the stent model was inconsistent with that labeled on the outer package.Another model was then opened and still inconsistent with that on the outer package (batch# nggu1616).Subsequently, the nurse was asked to open the package of the remaining products and found one more unit that was labeled with a model inconsistent with the actual one on the outer package (batch# nggv0729).A total of three units that were labeled with a model inconsistent with the actual one on the package.
Additional 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.
Event or Problem Description
It was reported that when placing the ureteral stent on (b)(6) 2023, the director and professor inspected the outer package of the corresponding model and found no problem with it.Upon opening of the package, they found that the stent model was inconsistent with that labeled on the outer package.Another model was then opened and still inconsistent with that on the outer package (batch# nggu1616).Subsequently, the nurse was asked to open the package of the remaining products and found one more unit that was labeled with a model inconsistent with the actual one on the outer package (batch# nggv0729).A total of three units that were labeled with a model inconsistent with the actual one on the package.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual evaluation noted one photo sample received.Photo sample shows stent removed from packaging with outer packaging as background.Stent indicates size as 4.7 fr x 26 cm.Outer product packaging indicates lot number nggu1616, product number 786626, size as 6 fr x 26 cm and expiration date as 25jan2026.Based on photo sample received product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be incorrect line clearance.A product was not used for patient diagnostic or treatment.The product was influenced by the reported event.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 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.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
• Common Device Name: 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 Key: 17343024
• Report Number: 1018233-2023-05259
• Device Sequence Number: 6903149
• Product Code: FAD
• UDI-Device Identifier: 10801741015127
• UDI-Public: (01)10801741015127
• 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): 09/18/2023

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: 01/25/2026
• Device Model Number: 786626
• Device Catalogue Number: 786626
• Device Lot Number: NGGU1616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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