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

Catalog Number 777626

Device Problem Incorrect Measurement (1383)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2023

Event Type  malfunction  

Event Description

It was reported that the model/specification was inconsistent with that of the ureteral stent tubing in the actual packaging.The actual stent tubing was thinner, incompatible with the associated guide wire, affecting the progress of the surgery and increasing the surgical costs.Stated that there was a surgical delay.

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 model/specification was inconsistent with that of the ureteral stent tubing in the actual packaging.The actual stent tubing was thinner, incompatible with the associated guide wire, affecting the progress of the surgery and increasing the surgical costs.Stated that there was a surgical delay.

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.

Manufacturer Narrative

The reported event is confirmed manufacturing related.Visual evaluation noted 19 samples were received in original closed packaging.6 kits were found containing incorrect stents as outer packaging label states kit contains 6 fr x 26 cm kit.However, as stent was removed from packaging 4.7 fr x 26 cm were found.Picture attached in the investigation overview element.Therefore, product does not meet specifications.The potential failure mode incorrect component.Based on this information the risk for this event is low.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review is not required as labelling review would not prevented the reported event.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 model/specification was inconsistent with that of the ureteral stent tubing in the actual packaging.The actual stent tubing was thinner, incompatible with the associated guide wire, affecting the progress of the surgery and increasing the surgical costs.Stated that there was a surgical delay.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ 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: 17798055
• MDR Text Key: 324025443
• Report Number: 1018233-2023-06987
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014557
• UDI-Public: (01)10801741014557
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• 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,Followup
• Report Date: 01/16/2024

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: 777626
• Device Lot Number: NGGY3400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/12/2023; 01/29/2024
• Supplement Dates FDA Received: 11/03/2023; 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2022
• 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