MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Proxis¿ Ureteral Access Sheath

Catalog Number	231245
Medical Device Problem Codes	Flaked (1246); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter complete facility name: (b)(6) hospital.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: 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 after removing the dilator, the sheath was peeling like a splinter on the inside of the sheath tip, end point.Per follow up information received via rcc on 19mar2026, stated that rather than complete detachment, it appears to be a fraying or splitting condition, though the exact nature was unclear and its use was discontinued immediately upon noticing the issue, so there were no residual fragments left in the body.

• Brand Name: Proxis¿ Ureteral Access Sheath
• Common Device Name: Ureteral Access 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 ; +1(770)784-6100
• MDR Report Key: 24656979
• Report Number: 1018233-2026-01926
• Device Sequence Number: 20097419
• Product Code: FED
• UDI-Device Identifier: 00801741101724
• UDI-Public: (01)00801741101724(11)250527(17)280527(10)BMKSFM12
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: 231245
• Device Lot Number: BMKSFM12
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 03/21/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• 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