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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

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C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES Back to Search Results
Model Number A303316A
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2020
Event Type  malfunction  
Event Description
The patient was admitted for an interventional radiology procedure.Prior to starting the procedure, a foley catheter was to be placed.The staff were aware of her latex allergy, therefore the packaging was closely inspected to ensure the catheter was latex-free prior to placement.As the nurse found no notation regarding the presence of latex, the foley was placed.The nurse feeling unsure, called the company and confirmed the foley did contain "natural rubber latex".The foley was immediately removed and a latex-free foley was placed.No harm came to the patient.Later, the nurse asked three other people to inspect the packaging of an unopened catheter kit; none of the clinicians found the alert.On the front of the packaging there is an abundant amount of information including cdc guidelines for indwelling catheters, questions to be asked prior to placement, uti occurrence information, etc.The information regarding the kit containing latex and iodine appears on the short side of the kit; the same side as the flap used to open the kit.The flap obscures the information pertinent to potential allergies as a portion of the flap is a solid white material versus the clear outer wrap over the remaining kit.In additional the font is very small.Any allergy potential should be included on the front of the packaging in such a way to draw the users eye to the information.
 
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Brand Name
SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®
Type of Device
CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
Manufacturer (Section D)
C. R. BARD, INC.
8195 industrial blvd
covington GA 30014
MDR Report Key9693362
MDR Text Key178568926
Report Number9693362
Device Sequence Number1
Product Code MJC
UDI-Device Identifier00801741073793
UDI-Public(01)00801741073793
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 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA303316A
Device Catalogue NumberA303316A
Device Lot NumberNGDS2288
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/24/2020
Event Location Hospital
Date Report to Manufacturer02/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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