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 03/24/2023

Event Type  Injury  

Event Description

It was reported that prior to insertion of the ureteral stent on march 24, the inspection was made when opening the package, and 787626 (6fr) was showed on labelling of the package with the lot no.Nggv5419.The stent was intact.But after taking stent tubing out of package, it was found that the size was 4.7 fr.The user replaced the product and surgical time was prolonged.Also stated that there was a surgical delay.

Manufacturer Narrative

The reported event is confirmed, cause unknown.No physical sample was returned, however, a photo sample was submitted.Visual evaluation of the photo sample noted the box label with lot nggv5149 and 6 fr.X 26 cm listed on the label; the photo shows the stent outside the packaging with 4.7f x 26cm printed on the stent body.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 resterilize".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.The actual/suspected device was inspected.

• Brand Name: BARD® INLAY OPTIMA® 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: 16732184
• MDR Text Key: 313213070
• Report Number: 1018233-2023-02527
• 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: Physician
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/13/2023
• 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): Required Intervention