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

Catalog Number 788626

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2023

Event Type  malfunction  

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 Description

It was reported that the patient had ureteral stenosis and needs to use a ureteral stent.When preparing for surgery, after opening the carton package on the outside of the stent, it was found that the inner packaging of the stent was not closed, which was considered to be no longer a sterile environment and could not be used.After replacing the new stent, the operation was continued to be completed, and the compensation for the problem stent was now applied.

Event Description

It was reported that the patient had ureteral stenosis and needs to use a ureteral stent.When preparing for surgery, after opening the carton package on the outside of the stent, it was found that the inner packaging of the stent was not closed, which was considered to be no longer a sterile environment and could not be used.After replacing the new stent, the operation was continued to be completed, and the compensation for the problem stent was now applied.

Manufacturer Narrative

The reported event is inconclusive due to the condition of the sample received.Visual evaluation noted received 1 ureteral stent kit in original opened package.Upon unpacking sample inner package only contained push catheter not the stent.First photo sample shows top view of enclosed kit in original closed packaging.Packaging label indicates correct lot number, pcn, size, and expiration of product.Second photo sample shows side profile of package open showing only push catheter.Third photo sample shows top view outer package box for ureteral kit.Therefore, it is unknown if the product meets specifications.Although an exact root cause could not be determined a potential root cause could be inappropriate package design.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review is not required as labelling would not have prevented the reported event.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.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• Type of Device: 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: 18329113
• MDR Text Key: 330974446
• Report Number: 1018233-2023-08935
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741015762
• UDI-Public: (01)00801741015762
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 788626
• Device Lot Number: NGGT3454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other