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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD BUTTON CONTINUOUS FEEDING TUBES WITH 90° ADAPTOR (NON-STERILE)

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BARD PERIPHERAL VASCULAR, INC. BARD BUTTON CONTINUOUS FEEDING TUBES WITH 90° ADAPTOR (NON-STERILE) Back to Search Results
Model Number 000258
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation; therefore, the investigation is inconclusive for device leak 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 Description
This report summarizes one malfunction. A review of the reported information indicated that model 000258 feeding tube allegedly experienced a leak. This information was received from a single source. The malfunction involved a patient with no reported consequence. The patient¿s age, weight, and sex were not provided.
 
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Brand NameBARD BUTTON CONTINUOUS FEEDING TUBES WITH 90° ADAPTOR (NON-STERILE)
Type of DeviceFEEDING TUBE
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD SHANNON LIMITED
san geronimo industrial park
lot #1, road #3, km 79.7
humacao 00791
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8796402
MDR Text Key151288413
Report Number3006260740-2019-01970
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number000258
Device Catalogue Number000258
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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