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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY NBR 20 FR; FEEDING DEVICE
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BARD ACCESS SYSTEMS PONSKY NBR 20 FR; FEEDING DEVICE Back to Search Results
Model Number 000702
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation; therefore, the investigation is inconclusive for the foreign material present in device as no objective evidence has been provided to confirm any alleged deficiency with the device.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.A review of the reported information indicated that model 000702, feeding device allegedly experienced foreign material present in the device.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.
 
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Brand Name
PONSKY NBR 20 FR
Common Device Name
FEEDING DEVICE
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8796607
Report Number3006260740-2019-01974
Device Sequence Number1822861
Product Code KNT
UDI-Device Identifier00801741036293
UDI-Public(01)00801741036293
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) 07/16/2019
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 Number000702
Device Catalogue Number000702
Device Lot NumberREBZ0337
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2019
Initial Report FDA Received Date07/16/2019
Patient Sequence Number1
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