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

Catalog Number	995081
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
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 before use, physicians attempted several times to ballooning the balloon dilation catheter, but it was unsuccessful.Balloon did not inflate.
Additional Manufacturer Narrative
The reported event was unconfirmed.The samples were evaluated in the engineering lab.Visual inspection was completed with the use of a 0.038 guide wire.It was confirmed that the 0.38 guidewire passed freely through the hub and the shaft of the catheter.No resistance was felt upon insertion of the guidewire.Then using the balloon hub, the catheter was inflated using di water and inflation device.The balloon was inflated to 8atms and evaluated.During this evaluation, there was no leaks observed and no deformation of the balloon or balloon tip.The balloon inflated properly and as intended of the final device.The balloon was then pressurized to 30atms and no leaks, deformations or irregularities were observed in the balloon.The balloon inflated properly as intended of the final device.The hubs were also inspected during pressurized and there were no deformities or leaks discovered in the hubs of the catheter.The balloon was then deflated using vacuum in the inflation device.No obstruction or occasions were found during the deflation of the catheter.Labelling review is not required as the reported event is unconfirmed.Dhr review is not required as the reported event is unconfirmed.No additional actions can be taken at this time.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 before use, physicians attempted several times to ballooning the balloon dilation catheter, but it was unsuccessful.Balloon did not inflate.Per follow up information received via ibc on 12jul2025, customer confirmed that 1 product was affected.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Common Device Name: 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: 22458426
• Report Number: 1018233-2025-05671
• Device Sequence Number: 8315701
• Product Code: LJE
• UDI-Device Identifier: 00801741080715
• UDI-Public: (01)00801741080715(11)230404(17)251114(10)BMHQFM17
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/28/2026

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 Expiration Date: 11/14/2025
• Device Catalogue Number: 995081
• Device Lot Number: BMHQFM17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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