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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 12F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 12F; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 000712
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/16/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number was not provided, a review of the device history records has not been performed.The device has been returned for evaluation.The investigation is currently underway.
 
Event or Problem Description
It was reported that during inflation the feeding device balloon allegedly leaked sterilized water from the shaft.There was no patient contact.
 
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Brand Name
TRI-FUNNEL REPL GAST 12F
Common Device Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9216415
Report Number3006260740-2019-03256
Device Sequence Number18918257
Product Code KNT
UDI-Device Identifier00801741037115
UDI-Public(01)00801741037115
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K063118
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number000712
Device Catalogue Number000712
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/24/2019
Initial Report FDA Received Date10/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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