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

Catalog Number	995081
Medical Device Problem Code	Material Fragmentation (1261)
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, the sheath in green portion of the balloon dilation catheter was broken.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used balloon dilation catheter.Visual inspection of the sample noted that the green sheath was broken.A sample of an encrusted stent was received in a ziplock bag.Visual inspection (via provided photos) confirmed encrustation on the pigtails.The device history record (dhr) was reviewed, and all tests, including cof testing for sub assembly coated part numbers, passed qc aql inspection.Coating operations were performed.During coating, stents are wiped with a 75/25 alcohol acetone blend to ensure surface cleanliness.Improper cleaning can affect coating adhesion.Depth settings on the coating machine must be correct; if too short, portions of the stent may remain uncoated.Proper curing occurs after coating, and any handling before curing can remove or damage the coating.Insufficient cure time can also impact coating integrity.Overall, the review indicates that coating quality depends heavily on correct stent cleaning, machine depth settings, and proper curing time.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Initial reporter complete facility name: (b)(6) hospital.Udi format updated with available product information per gudid.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 before use, the sheath in green portion of the balloon dilation catheter was broken.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: 22458578
• Report Number: 1018233-2025-05672
• Device Sequence Number: 12872540
• Product Code: LJE
• UDI-Device Identifier: 00801741080715
• UDI-Public: (01)00801741080715(11)230510(17)251128(10)BMHRFM11
• 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): 02/26/2026

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 Expiration Date: 11/28/2025
• Device Catalogue Number: 995081
• Device Lot Number: BMHRFM11
• 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: 02/26/2026
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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