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

Catalog Number 786626

Device Problem Wrong Label (4073)

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

Event Date 11/10/2023

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 after investigation, there were 3 sets of 786626 where the packaging did not match with the actual product inside, which was 4.7fr brackets.Per additional information via email from ibc on 14nov2023, the package includes a nitinol guidewire and a 4.7fr bracket.

Event Description

It was reported that after investigation, there were 3 sets of 786626 where the packaging did not match with the actual product inside, which was 4.7fr brackets.Per additional information via email from ibc on 14nov2023, the package includes a nitinol guidewire and a 4.7fr bracket.

Manufacturer Narrative

The reported event is confirmed.Visual evaluation noted received 3 ureteral stents in original closed packaging.Upon unpacking samples it was found in all returned samples that the contained incorrect stent size of 4.7 fr x 26 cm was packaged.Also received 2 photo samples.First photo sample shows one individual package from top view.Second photo sample shows top view of all 3 ureteral stents in original closed packaging.Therefore, product does not meet specifications.The root cause is product mix potentially occurred during an incorrectly segregated and returned material process in combination with a poorly performed line release.Labeling review, and dhr review are not required.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.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
• 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: 18220416
• MDR Text Key: 329351767
• Report Number: 1018233-2023-08601
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015127
• UDI-Public: (01)10801741015127
• 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: 03/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 786626
• Device Lot Number: NGGT3454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/28/2023
• 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