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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 24F X 2.4 CM BUTTON KIT FEEDING TUBE

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BARD ACCESS SYSTEMS 24F X 2.4 CM BUTTON KIT FEEDING TUBE Back to Search Results
Model Number 000286
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
For the reported event, lot number was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The device was labeled for single use.
 
Event Description
This report summarizes one malfunction. A review of the reported information indicated that model 000286 feeding tube allegedly experienced leak / splash. It was further reported that another device was used to complete the procedure. This report was received from a single source. This event did involve patient with no reported patient injury. The patient is (b)(6) years old, female; however, weight was not provided.
 
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Brand Name24F X 2.4 CM BUTTON KIT
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 Key9587239
MDR Text Key190608539
Report Number3006260740-2020-00068
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 03/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number000286
Device Catalogue Number000286
Device Lot NumberHUBY0562
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 Received03/25/2020
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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