MAUDE Adverse Event Report: BARD BARD INLAY URETERAL STENT 4.7 FR X 24 CM JJ STENT; STENT, URETERAL

Lot Number NGBW3961

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/18/2021

Event Type  malfunction  

Event Description

Stent was found in the abdomen outside the ureter.There is a pigtail catheter adjacent to the anterior and medial aspect of the right ureter, this is external to the ureter and not in bowel.This was likely a ureteral stent; recommend clinical correlation.This has been placed in the interval.Fda safety report id # (b)(4).

• Brand Name: BARD INLAY URETERAL STENT 4.7 FR X 24 CM JJ STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BARD; salt lake city UT 84116
• MDR Report Key: 12569053
• MDR Text Key: 274747105
• Report Number: MW5104347
• Device Sequence Number: 1
• Product Code: FAD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2021

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 Expiration Date: 03/20/2022
• Device Lot Number: NGBW3961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 87