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

Model Number 788828

Device Problems Expiration Date Error (2528); Device Handling Problem (3265)

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

Event Date 04/20/2022

Event Type  malfunction  

Event Description

It was reported that the expired ureteral stent was implanted.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the expired ureteral stent was implanted.

Manufacturer Narrative

The reported event was confirmed as user related.1sample was confirmed to exhibit the reported failure.It was unknown whether the device had met relevant specifications.The product was used for patient treatment.Visual evaluation of the returned photo sample noted one opened (with original packaging), inlay optima stent.Visual inspection of the photo sample noted that the expiry date (b)(6) 2022 on the inlay optima stent packaging.Per jde, lot expiry date for (b)(6) is (b)(6) 2022.A potential root cause for this failure mode could be ¿user related".The device history record review was not required as the event is use related.The instructions for use were found adequate and state the following: ¿includes: ureteral stent with suture pigtail straightener push the catheter with radiopaque band the lot #(b)(6) and use by date 2022-04-13¿ ]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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14428323
• MDR Text Key: 291947808
• Report Number: 1018233-2022-03835
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741015939
• UDI-Public: (01)00801741015939
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/10/2022

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 Expiration Date: 04/13/2022
• Device Model Number: 788828
• Device Catalogue Number: 788828
• Device Lot Number: NGCP2025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• 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