MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® VERSA FIT® URETERAL STENT

Catalog Number	778400
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
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.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 customer had a defective stent during surgery.The pusher (orange) was larger in lumen size and the stent, so it was sliding over the stent not pushing it up.
Additional Manufacturer Narrative
The reported event is unconfirmed as the product meets specifications.No root cause could be found because the reported event was unconfirmed.Dhr review is not required as the reported event is unconfirmed.Labelling review is not required as the reported event is unconfirmed.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that customer had a defective stent during surgery.The pusher (orange) was larger in lumen size and the stent, so it was sliding over the stent not pushing it up.Per additional information received via sample form on 06feb2024, during the procedure the surgeon was advancing the stent up the ureter to the position using the pusher (orange piece).The pusher slid over the end of the stent caused it to become stuck.The surgeon removed both the stent and the pusher and placed a new stent.The lumen of the pusher (orange) was larger than the diameter of the stent caused it to slide over the stent instead of pushed it up.No patient impact due to the use of the device.No medical intervention required.Device was replaced with a new stent.

• Brand Name: BARD® INLAY® VERSA FIT® URETERAL STENT
• Common Device Name: URETERAL STENT
• 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: 18535032
• Report Number: 1018233-2024-00153
• Device Sequence Number: 6732142
• Product Code: FAD
• UDI-Device Identifier: 00801741014710
• UDI-Public: (01)00801741014710
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: 778400
• Device Lot Number: NGHT0135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2023
• 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