MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 PROXIS¿ URETERAL ACCESS SHEATH; URETERAL SHEATH

Catalog Number	231025
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
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 the ureteral access sheath handle part was broken and cannot be used.
Additional Manufacturer Narrative
The reported event was confirmed - cause unknown.Visual: the sample was provided in the original bard pouch and placed inside the large ziploc bag.Sample packaging was open with no signs of external damage besides where seal was pulled apart.Tab for broken locking mechanism loose in ag.Sample was reviewed physically and there appears to have been a clean break of the locking mechanism.The only signs of stress to the material are at the corners where material separated.The dhr and subassembly dhrs were reviewed.The material goes though three 100% visual inspections of the locking mechanism hub for cracks, deformities, short shots, voids, or any damage throughout the manufacturing process.Once during the initial mold of material, once during the snapping of dilator and sheath part numbers, and again at packaging.Only one lot of subassembly material notes the scrap of material for "bad hubs" no other description of the defects were provided.The specific defect could occur at multiple places throughout manufacture process due to diameter of the section of the hub.The labelling was reviewed and found to be adequate.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: 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.
Event or Problem Description
It was reported that the ureteral access sheath handle part was broken and cannot be used.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Common Device Name: URETERAL SHEATH
• 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: 22383944
• Report Number: 1018233-2025-05419
• Device Sequence Number: 12927514
• Product Code: FED
• UDI-Device Identifier: 00801741101670
• UDI-Public: (01)00801741101670(11)241118(17)271101(10)BMJXFM30
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K160861
• 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 Catalogue Number: 231025
• Device Lot Number: BMJXFM30
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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