MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED

Catalog Number	123516A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/19/2025
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.This report references a us equivalent device.The us udi equivalent for this product number is used.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 about more than a month ago, the patient suddenly developed right-sided lumbar and abdominal pain without any obvious cause.The pain recurred repeatedly, with paroxysmal intensification.When the pain was severe, it was accompanied by nausea and an urge to vomit, but no gross hematuria was observed.Over the past month, there was no significant improvement, so the patient was admitted to our hospital for further diagnosis and treatment.After admission, relevant examinations were completed.On (b)(6) 2025, at 14:00, the patient underwent right flexible ureteroscopy and laser lithotripsy (fursl) surgery and ureteral stent placement under general anesthesia.After surgery, a urinary foley catheter was inserted and retained.At 20:55, during a ward round, it was discovered that the patient's catheter had fallen out.Upon checking the balloon, it was found to be ruptured, though the stent was intact, which delayed catheterization.The on-duty doctor was immediately informed, and medical orders were given to discontinue the indwelling catheter, increase water intake, and monitor the patient's urination.At 21:10, the patient did not report any discomfort and was able to urinate spontaneously, and the adverse event improved.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be user related (example: contact with sharp object)/exposure to petrolatum based products/mechanical failure/operator error).A review of the device labelling has been conducted for investigation purposed.The labeling and instructions for use were found to be adequate.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.This report references a us equivalent device.The us udi equivalent for this product number is used.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 about more than a month ago, the patient suddenly developed right-sided lumbar and abdominal pain without any obvious cause.The pain recurred repeatedly, with paroxysmal intensification.When the pain was severe, it was accompanied by nausea and an urge to vomit, but no gross hematuria was observed.Over the past month, there was no significant improvement, so the patient was admitted to our hospital for further diagnosis and treatment.After admission, relevant examinations were completed.On (b)(6) 2025, at 14:00, the patient underwent right flexible ureteroscopy and laser lithotripsy (fursl) surgery and ureteral stent placement under general anesthesia.After surgery, a urinary foley catheter was inserted and retained.At 20:55, during a ward round, it was discovered that the patient's catheter had fallen out.Upon checking the balloon, it was found to be ruptured, though the stent was intact, which delayed catheterization.The on-duty doctor was immediately informed, and medical orders were given to discontinue the indwelling catheter, increase water intake, and monitor the patient's urination.At 21:10, the patient did not report any discomfort and was able to urinate spontaneously, and the adverse event improved.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY CATHETER
• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23811717
• Report Number: 1018233-2025-11205
• Device Sequence Number: 7685903
• Product Code: EZC
• UDI-Device Identifier: 00801741095092
• UDI-Public: (01)00801741095092(230613(17)280228(10)MYHQ4630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 123516A
• Device Lot Number: MYHQ4630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• 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