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

Model Number 000718

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 10/25/2019

Event Type  malfunction  

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 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
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10099254
• MDR Text Key: 195593409
• Report Number: 3006260740-2020-01868
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K063118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1