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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 18F; FEEDING DEVICE
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BARD ACCESS SYSTEMS BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 18F; FEEDING DEVICE Back to Search Results
Model Number 000256
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the event is unknown, therefore the manufacturing review could not be conducted.The device has not been returned for evaluation; therefore, the investigation is inconclusive for fracture as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the event indicated that model 000256 feeding device experienced a fracture.This event was reported from a single source.This event involved a patient with no reported injury.The patient was reported as a (b)(6)-year-old female weighing (b)(6) lbs.
 
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Brand Name
BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 18F
Common Device Name
FEEDING DEVICE
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8529940
Report Number3006260740-2019-01027
Device Sequence Number11452713
Product Code KGC
UDI-Device Identifier00801741080821
UDI-Public(01)00801741080821
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/18/2019
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 No Information
Device Model Number000256
Device Catalogue Number000256
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2019
Initial Report FDA Received Date04/18/2019
Patient Sequence Number1
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