MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 000720

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: device history records (dhr) review was not possible to be performed due to no lot number was reported for investigation.Investigation summary: the sample returned for evaluation was one 20 fr tri-funnel replacement gastrostomy feeding tube.Visual and functional evaluations were performed of the physical sample.The sample's balloon was capable of inflating and aspirating, with no leaks observed.Deflation of the balloon was found to be difficult.The balloon material had a distended shape memory and a large amount of usage discoloration.Inflation of the balloon revealed that the balloon appeared to be asymmetric - it inflated more on one side than on the other.The manufacturing site performed an evaluation of the sample, as follows: the complaint was confirmed as cause unknown for the reported issue; per visual inspection evaluation body sediments were observed along the balloon, no other defects were noted.During functional evaluation the balloon was inflated with air using a syringe and no issues were found.The balloon was then inflated with 20 cc with a mix of tap water and blue methylene using a syringe and then left to deflate on its own, it was noted that some water remain in the balloon and extra force was used to remove all the water.An asymmetrical balloon was observed.The balloon was then cut to inspect the notch and no issues were found.The reported difficult deflation of the balloon appears to be caused by the defective balloon; therefore, this investigation is unconfirmed for difficult to deflate and confirmed for balloon defective.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: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, possible complications and contraindications showed that the product labeling is adequate.

Event Description

It was reported during removal of the device, that water was allegedly unable to be removed from the balloon.There was no reported patient injury.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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 -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8226621
• MDR Text Key: 132372074
• Report Number: 3006260740-2018-03832
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741037153
• UDI-Public: (01)00801741037153
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2019

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
• Device Operator: Health Professional
• Device Model Number: 000720
• Device Catalogue Number: 000720
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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