MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 12F; FEEDING DEVICE

Model Number	000712
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photos were provided to the manufacturer for review.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.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that there was an alleged leak at the probe through the feeding tube.There was no reported patient injury.
Additional Manufacturer Narrative
The lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: although the sample was not returned for evaluation, one electronic video was provided for review.The investigation is confirmed for feeding tube break, as video shows a portion of the tri-funnel feeding tube near between the tri-funnel and the catheter.It shows a fluid leak in the feeding tube near the tri-funnel.The definitive root cause could not be determined based upon available information.It is unknown if clinical or manufacturing procedures contributed to the reported event.Possible contributing factors include sharp instrument damage, excessive force, and material fatigue; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that there was an alleged leak at the probe through the feeding tube.There was no reported patient injury.

• Brand Name: TRI-FUNNEL REPL GAST 12F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8248518
• Report Number: 3006260740-2018-03874
• Device Sequence Number: 16503660
• Product Code: KNT
• UDI-Device Identifier: 00801741037115
• UDI-Public: (01)00801741037115
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,user facilit
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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 Number: 000712
• Device Catalogue Number: 000712
• Device Lot Number: NGCU2485
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 04/26/2019
• 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: MILK 80CC, ANTICONVULSANT 0.6CC; MILK 80CC, ANTICONVULSANT 0.6CC; MILK 80CC, ANTICONVULSANT 0.6CC