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

Model Number	231025
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 upon completion of the case, the operator was not able to remove the access sheath from the scope.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure, which in turn, may result in patient injury, illness or death." do not bend the device prior to placement as this could damage the integrity of the device and result in patient injury." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that upon completion of the case, the operator was not able to remove the access sheath from the scope.

• Brand Name: PROXIS URETERAL ACCESS SHEATH
• Common Device Name: PROXIS ACCESS SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10364537
• Report Number: 1018233-2020-04975
• Device Sequence Number: 3094800
• Product Code: FED
• UDI-Device Identifier: 00801741101670
• UDI-Public: (01)00801741101670
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: 10/15/2020
• Device Model Number: 231025
• Device Catalogue Number: 231025
• Device Lot Number: BMDXFM08
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1