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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM TUBE, GASTRO-ENTEROSTOMY

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BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Model Number 000282
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number for the event is unknown, therefore the manufacturing review could not be conducted. The device has not been returned for evaluation; therefore, the investigation is inconclusive for the reported 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 (1) malfunction event. A review of the event indicated that model 000282 gastrostomy tube experienced a leak. This event was reported from a single source. This event involved a patient with no reported injury. The patient¿s age, weight, sex were not provided.
 
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Brand NameBARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM
Type of DeviceTUBE, GASTRO-ENTEROSTOMY
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
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8531958
MDR Text Key142517787
Report Number3006260740-2019-01041
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 04/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number000282
Device Catalogue Number000282
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 Received03/31/2019
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

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