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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event is inconclusive because no sample was returned and further investigation was not conclusive.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 was not returned for evaluation.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 resterlize".

Event Description

It was reported that the surgeon opened the package of the product and found that the size of the ureteral stent was 4.7 fr, which was inconsistent with that on the packaging label.The size on the label of the outer package was 6 fr, 26 cm.The product was therefore replaced and another one was used.The health care professional raised doubt about the quality of bd products, significantly affecting the brand¿s image and worried about the re-occurrence of similar event.

• 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: 16673440
• MDR Text Key: 313213891
• Report Number: 1018233-2023-02288
• Device Sequence Number: 1
• Product Code: FAD
• 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: 03/18/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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