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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP FOLEY TRAY SYSTEM BARDEX ALL-SILICONE FOLEY CATHETER TRAY
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C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP FOLEY TRAY SYSTEM BARDEX ALL-SILICONE FOLEY CATHETER TRAY Back to Search Results
Model Number A897516
Medical Device Problem Code Component Missing (2306)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The reported event is inconclusive since the device was not returned for evaluation.A potential root cause identified was "incorrect operation".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.".
 
Event or Problem Description
It was reported that the 100 cc sterile water syringe was missing from the tray.
 
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Brand Name
SURESTEP FOLEY TRAY SYSTEM BARDEX ALL-SILICONE FOLEY CATHETER TRAY
Common Device Name
FOLEY TRAY
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8932849
Report Number1018233-2019-05122
Device Sequence Number1948325
Product Code EZL
UDI-Device Identifier00801741073984
UDI-Public(01)00801741073984
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K040504
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/26/2019
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
Operator of Device Health Professional
Device Model NumberA897516
Device Catalogue NumberA897516
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/09/2019
Initial Report FDA Received Date08/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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