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

Catalog Number 788626

Device Problems Material Too Rigid or Stiff (1544); Material Protrusion/Extrusion (2979)

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

Event Date 10/07/2023

Event Type  malfunction  

Event Description

It was reported that the stent tube was not smooth enough to go up and was replaced with another one with the same specification to complete the operation.

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 stent tube was not smooth enough to go up and was replaced with another one with the same specification to complete the operation.

Manufacturer Narrative

The reported event is inconclusive due to the condition of the sample received.Visual evaluation noted three photo samples received.First photo sample shows stent and push catheter on top of packaging.Second photo sample zooms in on packaging showcasing lot number, expiration date, and product catalog number.Third photo sample zooms in on pack of packaging box with label in native language.Based on quality and condition of the photo sample received it is unknown if the product meets specifications.Although an exact root cause could not be determined a potential root cause could be defective components from supplier/ with contamination.A dhr review did not show any problems or conditions that would have contributed to the reported event.The labelling review is not required as labelling would not have prevented the reported event.Correction: d,e,f,h 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
• 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: 18039693
• MDR Text Key: 326974591
• Report Number: 1018233-2023-07746
• Device Sequence Number: 1
• Product Code: FAD
• 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: 01/31/2024

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: NGGY2967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2022
• 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