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

Catalog Number	777414
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Udi format updated with available product information per gudid.H11: sections 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 or Problem Description
It was reported that three years ago, the patient experienced lower back pain during urination but did not seek specific treatment.About 20 days ago, they developed painless gross hematuria throughout urination without any obvious caused and sought treatment at (b)(6) hospital of (b)(6).Seeking further diagnosis and treatment, they came to their hospital today and was admitted to their department with a diagnosis of hydro nephrosis with ureteral stones right ureteral stone, left adrenal tumor, diabetes, and hypertension.From 13:40 to 15:25 on (b)(6) 2025, the patient underwent a left adrenal tumor resection in the retroperitoneal cavity under general anesthesia.A ureteral stent was used during the surgery, but upon opening that, the packaging was found to be damaged, rendering and unusable.After replacement, the surgery proceeded smoothly.That incident occurred during the surgical procedure and neglected to address that afterward could easily lead to serious harm.The product aseptic packaging was damaged (seal failure), rendering that unusable.Preliminary speculation suggests that the product's usage date (b)(6) 2025) was too far from its production date (b)(6) 2023), leading to the failure of the aseptic packaging seal.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23764875
• Report Number: 1018233-2025-10916
• Device Sequence Number: 16100603
• Product Code: FAD
• UDI-Device Identifier: 10801741014441
• UDI-Public: (01)10801741014441(11)230201(17)270714(10)NGHN3380
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 777414
• Device Lot Number: NGHN3380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown