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

Model Number	231025
Medical Device Problem Codes	Disconnection (1171); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the access sheath broke in the patient.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.No physical sample was returned, however, a photo sample was submitted.The sheath was noted to be completely detached from the hub; the device does not meet visual specifications.A potential root cause for this event could be, "part geometry/dimensions".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: "contraindications: patients who have the presence of tight strictures which would limit use of the device." "to minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement." "do not bend the device prior to placement as this could damage the integrity of the device and result in patient injury." "do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action." 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 inspected.
Event or Problem Description
It was reported that the access sheath broke in the patient.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14497759
• Report Number: 1018233-2022-04101
• Device Sequence Number: 5579267
• Product Code: FED
• UDI-Device Identifier: 00801741101670
• UDI-Public: (01)00801741101670
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: 11/05/2024
• Device Model Number: 231025
• Device Catalogue Number: 231025
• Device Lot Number: BMFYFM14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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