MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 16F; FEEDING DEVICE

Model Number	000716
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing 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.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that approximately one month post gastrostomy surgery the feeding tube balloon allegedly deflated.It was further reported that the device was removed and replaced.There was no reported patient injury.
Event or Problem Description
It was reported that approximately one month post gatrostomy surgery the feeding tube balloon allegedly deflated.It was further reported that the device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a manufacturing 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.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: g4.H11: the date of awareness corrected.F12.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: TRI-FUNNEL REPL GAST 16F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9806587
• Report Number: 3006260740-2020-00785
• Device Sequence Number: 11513838
• Product Code: KNT
• UDI-Device Identifier: 00801741037139
• UDI-Public: (01)00801741037139
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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 Number: 000716
• Device Catalogue Number: 000716
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRIHEPTANOIN, 36 ML, 30 TOTAL DOSES.; TRIHEPTANOIN, 36 ML, 30 TOTAL DOSES.
• Patient Age: 1 YR