MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 14F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000714
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was not required to be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 02/2023).
Event or Problem Description
It was reported that approximately two weeks post feeding tube placement, the balloon allegedly deflated and a leak of sterile water was identified.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number was provided and a lot history review was performed.Investigation summary: one tri-funnel 14f and two electronic photos were returned for evaluation.First photo shows the trifunnel with a three-way stopcock valve attached to the proximal hub of the device.The second photo shows the distal end of the feeding tube and clear fluid residue can be seen on the deflated balloon.Visual and functional testing were performed.The sample was returned with a three-way stopcock valve attached to the proximal hub of the device.Residue was noted throughout.The balloon was inflated with approximately 5.0ml of water and was allowed to sit for 10 minutes.The balloon was massaged and no leaks were noted.The balloon was deflated without issue.The investigation is unconfirmed for the alleged leak in the balloon as the failure could not be recreated under laboratory settings.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: g4, d4 (expiration date: 02/2023), h6 (method) h11: a1, d2, h3, h6 (results, conclusions) 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.
Event or Problem Description
It was reported that approximately two weeks post feeding tube placement, the balloon allegedly deflated and a leak of sterile water was identified.There was no reported patient injury.

• Brand Name: TRI-FUNNEL REPL GAST 14F
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9823417
• Report Number: 3006260740-2020-00801
• Device Sequence Number: 16926500
• Product Code: KNT
• UDI-Device Identifier: 00801741037122
• UDI-Public: (01)00801741037122
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 000714
• Device Catalogue Number: 000714
• Device Lot Number: NGDV0491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1