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

Model Number	231225
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
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.The device was not returned.
Event or Problem Description
It was reported that the package was found to be broken so it was not kept sterile and not used.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause could be due to an " inappropriate package design¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported even appears to be alleging an even against as damaged packaging and the no patient involvement, labeling review was not performed as it is unlikely that the user would cause this issue.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 the package was found to be broken so it was not kept sterile and was not used.

• Brand Name: PROXIS URETERAL ACCESS SHEATH
• Common Device Name: UTERAL ACCESS SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10563423
• Report Number: 1018233-2020-06103
• Device Sequence Number: 1167913
• Product Code: FED
• UDI-Device Identifier: 00801741101700
• UDI-Public: (01)00801741101700
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 04/01/2023
• Device Model Number: 231225
• Device Catalogue Number: 231225
• Device Lot Number: BMEQFM08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1