MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 18F; FEEDING TUBE

Model Number	000718
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither a lot history review nor a device history review could be performed as the lot number was not provided.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.One tri-funnel replacement gastrostomy tube 18f (b)(4) was returned for evaluation.Visual, and functional testing were performed.Blood and residue were noted throughout.The balloon was inflated but as soon as the syringe was removed, an immediate backflow of the water was observed and the balloon deflated.However, there was no leaks throughout the catheter and the water flowed back out through the inflation hub.The investigation is confirmed for the alleged balloon leak.The definitive root cause could not be determined based upon available information.
Event or Problem Description
It was reported that during gastrostomy feeding tube preparation, during inflating the balloon, an alleged leak of water was found prior to use on patient which rendered the device unusable.Reportedly, another device was used to perform the procedure.There was no patient contact.

• Brand Name: TRI-FUNNEL REPL GAST 18F
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10099254
• Report Number: 3006260740-2020-01868
• Device Sequence Number: 3387406
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: Other
• Device Model Number: 000718
• Device Catalogue Number: 000718
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1