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® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
  • 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® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER Back to Search Results
Model Number 995081
Device Problems Inflation Problem (1310); Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2022
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 there was a balloon malfunction in the bard x-force nephrostomy balloon dilation catheter.Per follow up information received via ibc on 23may2022, it was reported that the catheter balloon failed to inflate fully.It was stated that the fault occurred during use, but no patient injury was reported and the procedure was completed by using another bard x-force nephrostomy balloon dilation catheter.
 
Event Description
It was reported that there was a balloon malfunction in the bard x-force nephrostomy balloon dilation catheter.Per follow up information received via ibc on 23may2022, it was reported that the catheter balloon failed to inflate fully.It was stated that the fault occurred during use, but no patient injury was reported and the procedure was completed by using another bard x-force nephrostomy balloon dilation catheter.
 
Manufacturer Narrative
The reported event is unconfirmed as the problem could not be reproduced.The balloon dilation catheter was returned opened with the original packaging.No visible anomalies were noted on the returned device.Functional testing was performed by introducing a guidewire through the wire hub, using the balloon hub the catheter was filled with distilled water using an inflation device.The balloon was inflated and then it was pressurized to 15, 20, 25 and then 30 atm without show of any leaks or irregularities.The device was used for treatment purposes.The dhr review is not required, as the reported event is 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.H3 other text : the actual/suspected device was inspected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
Type of Device
BALLOON DILATION CATHETER
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 Key14575910
MDR Text Key293258952
Report Number1018233-2022-04339
Device Sequence Number1
Product Code LJE
UDI-Device Identifier00801741080715
UDI-Public(01)00801741080715
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K063632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2024
Device Model Number995081
Device Catalogue Number995081
Device Lot NumberBMFUFM21
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2021
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;
-
-