Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILICONE URETERO-INTESTINAL ANASTOMOSIS URINARY DIVERSION STENT; URINARY STENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILICONE URETERO-INTESTINAL ANASTOMOSIS URINARY DIVERSION STENT; URINARY STENT Back to Search Results
Model Number 089007
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Pain (1994); Urinary Tract Infection (2120); Post Operative Wound Infection (2446); Dysuria (2684)
Event Date 03/25/2022
Event Type  Injury  
Event Description
It was reported that the survey respondent mentioned about urinary urgency, dysuria, suprapubic pain, surgical site infection, and urinary tract infection when asked of complications faced while using the urinary stent.It was unknown what medical intervention was provided.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "material selection".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "a variety of techniques may be used during stent placement.Each surgeon should use the methods with which he/she is familiar.1.During the surgical procedure, after the ureter has been divided, the stent is straightened by inserting the guidewire into the proximal end (open end) of the stent and advancing it forward to distal end (closed end).2.Pass the stent through the open end of the cut ureter up into the renal pelvis.3.While holding the proximal end, withdraw the guidewire.This will allow the ¿figure 4¿ to form within the renal pelvis thereby ensuring proper placement.4.After isolation of the bowel segment and closure of the distal end have been accomplished, pass a long right angle clamp through the stomal end to the point where the ureter is to be anastomosed.5.Draw the proximal end of the urinary diversion stent through the dissection to the stomal end.6.Palpate the renal pelvis to ensure proper placement of the distal end.7.After the external stoma has been formed, trim the stent so that approximately 5cm protrudes from the stoma.Then attach the stent to the skin with a nonabsorbable suture." the device was not returned.
 
Event Description
It was reported that the survey respondent mentioned about urinary urgency, dysuria, suprapubic pain, surgical site infection, and urinary tract infection when asked of complications faced while using the urinary stent.It was unknown what medical intervention was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BARD® SILICONE URETERO-INTESTINAL ANASTOMOSIS URINARY DIVERSION STENT
Type of Device
URINARY 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 Key14161086
MDR Text Key289690062
Report Number1018233-2022-02724
Device Sequence Number1
Product Code FAD
UDI-Device Identifier10801741011648
UDI-Public(01)10801741011648
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K823487
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number089007
Device Catalogue Number089007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2022
Initial Date FDA Received04/20/2022
Supplement Dates Manufacturer Received06/02/2022
Supplement Dates FDA Received06/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-