MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER

Catalog Number	996101
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter full facility name provided is (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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.
Event or Problem Description
It was reported that prior to performing ureteral stricture dilation surgery, when opening the ureteral stricture balloon for use, a noticeable leak was observed in the pressure pump.Replaced the balloon set.
Event or Problem Description
It was reported that prior to performing ureteral stricture dilation surgery, when opening the ureteral stricture balloon for use, a noticeable leak was observed in the pressure pump.Replaced the balloon set.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual inspection of the sample noted one inflation device and inflator tray was returned inside a ziplock bag (figures 1-2).The device exhibits the cts mark indicating 100 percent functional verification at the time of manufacture, and the gauge was in the zero box upon arrival.No visual abnormalities were noticed during the visual inspection of the device upon receipt.The device was connected to the pressure indicator, and the plunger was pulled outwards to fill the device with distilled water to aspirate it.The device was then pressurized, and as the pressure increased, the gauge needle did not move.There was no leak observed in any component of the device, the only abnormality being the gauge needle refusing to move.No root cause could be found because the reported event was unconfirmed.As the reported event is unconfirmed, a risk review is not required.As the reported event is unconfirmed, a labeling review is not required.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: d, e, h.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.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Common Device Name: BALLOON DILATION 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23485367
• Report Number: 1018233-2025-09975
• Device Sequence Number: 18698974
• Product Code: LJE
• UDI-Device Identifier: 10801741127660
• UDI-Public: (01)10801741127660(11)240930(17)270325(10)BMJWFM46
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 996101
• Device Lot Number: BMJWFM46
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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