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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BUTTON GASTROSTOMY FEEDING TUBE FEEDING DEVICE

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BARD ACCESS SYSTEMS BUTTON GASTROSTOMY FEEDING TUBE FEEDING DEVICE Back to Search Results
Model Number 000287
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2018
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. A photo of the device was provided for review. The investigation of the reported event is currently underway.
 
Event Description
It was reported that the button connections on the feeding tube were allegedly loose. It was further reported that medication administered through the feeding tube, would leak through the probe. The patient was not able to report any injury.
 
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Brand NameBUTTON GASTROSTOMY FEEDING TUBE
Type of DeviceFEEDING DEVICE
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
lot #1, road #3, km 79.7
salt lake city UT 84116
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 Key8227580
MDR Text Key132404011
Report Number3006260740-2018-03834
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K904779
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 06/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number000287
Device Catalogue Number000287
Device Lot NumberHUCQ0333
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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