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	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
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 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.
Event or Problem Description
It was reported that a urethral stent was required when performing ureteroscopic lithotripsy under general anesthesia at the hospital on (b)(6) 2023.When preparing the items, the nurse found that the model of the bard inlay optima ureteral stent was labeled as 786626.But after unpacking, the diameter of the content stent was shown as 4.7 f, inconsistent with that on the outer package, stent was used.The agent inspected the goods in this lot number and found nine stents having the problem.
Additional Manufacturer Narrative
The reported event was confirmed as packaging related.A potential root cause for this failure mode could be ¿incorrect component".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required as a review of the label could not have prevented the reported event.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 a urethral stent was required when performing ureteroscopic lithotripsy under general anesthesia at the hospital on (b)(6) 2023.When preparing the items, the nurse found that the model of the bard inlay optima ureteral stent was labeled as 786626.But after unpacking, the diameter of the content stent was shown as 4.7 f, inconsistent with that on the outer package, stent was used.The agent inspected the goods in this lot number and found nine stents having the problem.

• 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: 17623314
• Report Number: 1018233-2023-06329
• Device Sequence Number: 17967380
• 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): 10/30/2023

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: 08/26/2024
• Device Catalogue Number: 786626
• Device Lot Number: NGGT3454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 11/06/2023
• 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