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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX® ALL-SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON
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C. R. BARD, INC. BARDEX® ALL-SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number 165816
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/08/2023
Event Type  malfunction  
Event Description
Bard/bardex foley catheter packaging identifies that the balloon is 5cc's.The catheter identifies the balloon as being 10cc.Products not used on a patient, no known patient harm.4 catheters with this issue have been isolated.Manufacturer response for catheter, retention type, balloon, bardex® all-silicone foley catheter (per site reporter) will obtain.Manufacturer response for catheter, coude, bardex® lubricath® foley catheter (per site reporter) will obtain.Manufacturer response for catheter, coude, bard® foley catheter silicone coated (per site reporter) will obtain.Manufacturer response for catheter, retention type, balloon, bardex® all-silicone foley catheter (per site reporter) will obtain.
 
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Brand Name
BARDEX® ALL-SILICONE FOLEY CATHETER
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
C. R. BARD, INC.
8195 industrial blvd.
covington GA 30014
MDR Report Key17001623
MDR Text Key315925653
Report Number17001623
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741029752
UDI-Public(01)00801741029752(17)270314(10)NGGT3345
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/10/2023
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 Number165816
Device Catalogue Number165816
Device Lot NumberNGGT3345
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/10/2023
Event Location Hospital
Date Report to Manufacturer05/25/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/25/2023
Type of Device Usage Unknown
Patient Sequence Number1
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