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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F

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BARD ACCESS SYSTEMS BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F Back to Search Results
Model Number 000259
Device Problems Fluid Leak (1250); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed. The device was not returned to the manufacturer for evaluation; however photo was provided. The company is still investigating the issue at this time. The device is labeled for single use.
 
Event Description
This report summarizes one malfunction. A review of the reported information indicated that model 000259 feeding tube allegedly fluid leak and deformation due to compressive stress. This information was received from one source. One patient was involved with no reported patient injury. The device was used in a male patient. Age and weight of the patient was not provided.
 
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Brand NameBARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F
Type of DeviceFEEDING TUBE
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD SHANNON LIMITED
san geronimo industrial park
lot #1, road #3, km 79.7
humacao 00791
00791
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10737536
MDR Text Key213120081
Report Number3006260740-2020-03468
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,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number000259
Device Catalogue Number000259
Device Lot NumberHUDY1177
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2020
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

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