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

Model Number 778426

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2022

Event Type  malfunction  

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 Description

It was reported that the d-j stent was placed after the operation on (b)(6) 2022 in order to drain the hydronephrosis and the indwelling process during the operation was normal.It was considered that the diameter of the coiled segment of the proximal end of the dj tube was too small and it was difficult to stabilize it in the renal pelvis.The d-j stent fell off distally on the second day after the operation, which would partially affect the drainage of hydronephrosis.It was mentioned that the position of d-j tube was observed regularly.Due to the flow of water, dj tube was put in on (b)(6) 2022, the process of detention was normal, and the second day was released.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned for evaluation.As the sample was not returned for evaluation a specific root cause could not be determined, however, based on the risk document a potential root cause for this failure could be, "material selection, part geometry".The device was used for treatment purposes.As the device was not returned for evaluation it is unknown if it had met relevant specifications or resulted in the reported event.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.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 device was not returned.

Event Description

It was reported that the d-j stent was placed after the operation on 05aug2022 in order to drain the hydronephrosis and the indwelling process during the operation was normal.It was considered that the diameter of the coiled segment of the proximal end of the dj tube was too small and it was difficult to stabilize it in the renal pelvis.The d-j stent fell off distally on the second day after the operation, which would partially affect the drainage of hydronephrosis.It was mentioned that the position of d-j tube was observed regularly.Due to the flow of water, dj tube was put in on 05aug2022, the process of detention was normal, and the second day was released.

• Brand Name: BARD® INLAY® URETERAL STENT
• Type of Device: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15370480
• MDR Text Key: 305346668
• Report Number: 1018233-2022-06956
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014765
• UDI-Public: (01)00801741014765
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: 778426
• Device Catalogue Number: 778426
• Device Lot Number: NGDN0942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Male