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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 GASTRO-ENTEROSTOMY TUBE

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BARD ACCESS SYSTEMS BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F GASTRO-ENTEROSTOMY TUBE Back to Search Results
Model Number 000259
Device Problem Restricted Flow rate (1248)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a lot history review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation; therefore, the investigation of the reported event is inconclusive for low flow rate. A definitive root cause for the reported event could not be determined. The device is labeled for single use.
 
Event Description
This report summarizes one malfunction. A review of the reported information indicated that model 000259 gastro-enterostomy tube allegedly experienced restricted flow rate. This information was received from one source. The malfunction involved a patient with no known impact to the patient. The age, weight and gender of the patient were not provided.
 
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Brand NameBARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F
Type of DeviceGASTRO-ENTEROSTOMY 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 Key10737564
MDR Text Key213120825
Report Number3006260740-2020-03467
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 10/26/2020
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 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 Received09/30/2020
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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