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

Model Number 777626

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that inlay ureteral stent did not function and urine cannot flow out after placement.Another new inlay was used.

Manufacturer Narrative

The reported event is unconfirmed as the product met specifications.The ureteral stent and pusher were returned in opened packaging.An evaluation was completed by futurematrix on 22jul2021.The stent passed visual inspection which states to examine the sample with the unaided eye at 12" to 18" distance under normal room lighting.Port holes were present on the pigtails and body of the stent.The guidewire passage on the sample was tested using a 0.038 guidewire to ensure a clear passage, which was within specifications.The device was used for treatment purposes, the device met specifications, and did not contributed to the reported event.The device history record review was not required as the reported event was unconfirmed.As the reported event is unconfirmed, a label/packaging review is not required.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 Description

It was reported that the inlay ureteral stent did not function because urine would not flow out after placement.User had to use another new inlay.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11510094
• MDR Text Key: 243975205
• Report Number: 1018233-2021-01371
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014557
• UDI-Public: (01)10801741014557
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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
• Device Operator: Health Professional
• Device Model Number: 777626
• Device Catalogue Number: 777626
• Device Lot Number: NGEW3164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2020
• 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