• 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. BARD FOLEY TRAY WITH BARDEX ALL SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

  • 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. BARD FOLEY TRAY WITH BARDEX ALL SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number 897216
Device Problem Defective Device (2588)
Patient Problem Urinary Retention (2119)
Event Date 11/19/2020
Event Type  malfunction  
Event Description
Bard latex-free foley catheter, lot # ngev1612, exp date: 3/31/2023 placed.Labor nurse checked output an hour later and visualized clear light yellow urine in the tubing but no urine draining into foley bag.Patient had been voiding frequently prior to foley placement.Foley bag switched out for urometer bag with immediate drainage of large amount of urine.Foley bag appears to have membrane covering opening into bag that will not allow urine to drain through.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BARD FOLEY TRAY WITH BARDEX ALL SILICONE FOLEY CATHETER
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
C.R. BARD, INC.
1211 mary magnan blvd
madison GA 30650
MDR Report Key10991267
MDR Text Key220920000
Report Number10991267
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/25/2020
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 No Information
Device Model Number897216
Device Catalogue Number897216
Device Lot NumberNEGEV1012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/25/2020
Event Location Hospital
Date Report to Manufacturer12/11/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age7665 DA
Patient Weight113
-
-