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

Model Number 787626

Device Problem Inadequate Instructions for Healthcare Professional (1319)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event is inconclusive due to poor sample condition.No physical sample was returned, however, a photo sample was submitted.Visual evaluation of the photo sample noted the pouch label with lot nggv5149 and 6fr x 26cm listed.The stent was not pictured; therefore, unable to properly evaluate the reported event.Though a specific cause cannot be determined, based on the risk document potential root causes for this event could be, "multiple tally in the station during the label printing, typo error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warning: after use this product may be a potential biohazard.Handle and dispose of in accordance with medical practice and with applicable laws and regulations.Single use.Do not use if package is opened.Do not re-sterilize." the actual/suspected device was inspected.

Event Description

It was reported that the user had a ureteral stent in which 787626 (6f) was indicated on the outer package with lot number of nggv5419 in the morning of march 21.The stent was intact.But, after the stent tubing was removed from the package, the size was found to be 4.7fr.The same problem occurred with a replacement from the same batch.Therefore, another stent from another brand was inserted.The health care professional needed to replace the stent with another one, causing perplexity and a surgical delay.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Type of Device: GUIDEWIRE
• 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: 16712379
• MDR Text Key: 313012876
• Report Number: 1018233-2023-02434
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015448
• UDI-Public: (01)10801741015448
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2023

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 Model Number: 787626
• Device Catalogue Number: 787626
• Device Lot Number: NGGV5149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2022
• 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