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

Catalog Number	786626
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
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 patient underwent ureteral stent placement in the operating room, needed to use a 6f ureteral stent, used a 786626 stent set during the operation, and after inserting the guidewire, opened the stent package and found that the stent was a 4.7f stent, so it could not be used, and then replaced with a new stent and continued to complete the operation.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Addressed by capa 7548189/sa ucc-23-4744-sa.One photo was received for evaluation.It is evidenced the stent on top of the box.In the top label it says the size 6fr x 26 cm, however the stent says 4.7 fr x 26 cm.Received 1 ureteral stent kit in opened packaging.Per visual inspection of the stent, it was confirmed the incorrect size 4.7 fr x 26 cm.A dhr review and labelling review is not required as capa 7548189/sa ucc-23-4744 is applicable for the product lot number.Udi format updated with available product information per gudid.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 patient underwent ureteral stent placement in the operating room, needed to use a 6f ureteral stent, used a 786626 stent set during the operation, and after inserting the guidewire, opened the stent package and found that the stent was a 4.7f stent, so it could not be used, and then replaced with a new stent and continued to complete the operation.

• 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: 19285782
• Report Number: 1018233-2024-02655
• Device Sequence Number: 8473565
• Product Code: FAD
• UDI-Device Identifier: 10801741015127
• UDI-Public: (01)10801741015127(11)220903(17)240826(10)NGGT3454
• 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): 08/08/2024

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 Expiration Date: 08/26/2024
• Device Catalogue Number: 786626
• Device Lot Number: NGGT3454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2022
• 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