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

Model Number	231235
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
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.
Event or Problem Description
It was reported that attempting to insert the access sheath, the tip became slightly bent and could not be inserted properly.Also stated it was crashed.Per follow-up information received via ibc on (b)(6) 2023, stated that the japanese description says that the tip was bent, as if it had been crushed (pushed).
Event or Problem Description
It was reported that attempting to insert the access sheath, the tip became slightly bent and could not be inserted properly.Also stated it was crashed.Per follow-up information received via ibc on 06mar2023, stated that the japanese description says that the tip was bent, as if it had been crushed (pushed).
Additional Manufacturer Narrative
The reported event is unconfirmed as the reported failure could not be reproduced.Photo samples were submitted and the used access sheath was returned in the opened original packaging.Visual evaluation of the photo samples noted the access sheath present with and without the dilator.No deformities could be seen from the photo.Visual evaluation of the physical sample noted foreign matter, possibly from use, present on the inside and outer sheath.No breakage, bends or visible defects were noted.The device was attempted to be used for treatment purposes.As the reported event is unconfirmed, a dhr review is not required.As the reported event is unconfirmed, a labeling review is not required.H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was evaluated.

• 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 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16579262
• Report Number: 1018233-2023-01868
• Device Sequence Number: 11935468
• Product Code: FED
• UDI-Device Identifier: 00801741101717
• UDI-Public: (01)00801741101717
• 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): 05/12/2023

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: 02/24/2025
• Device Model Number: 231235
• Device Catalogue Number: 231235
• Device Lot Number: BMGPFM34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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