MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 20F; FEEDING

Model Number 000720

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint was originally determined to be a malfunction reportable event on (b)(6)2019 and reported to the fda through the quarterly voluntary malfunction summary reporting (vmsr) program.Bdpi received a notification from the fda on 9/16/2019 stating that the procode knt is ineligible for the vmsr program; therefore, the mdr date of awareness was modified to reflect the date of the fda notification of procode ineligibility.The lot number for the device was not provided, therefore the device history records could not be reviewed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during preparation, the feeding device balloon allegedly inflated asymmetrically.There was no reported patient involvement.

Manufacturer Narrative

The complaint was originally determined to be a malfunction reportable event on (b)(6) 2019 and reported to the fda through the quarterly voluntary malfunction summary reporting (vmsr) program.Bdpi received a notification from the fda on 9/16/2019 stating that the procode knt is ineligible for the vmsr program; therefore, the mdr date of awareness was modified to reflect the date of the fda notification of procode ineligibility.Manufacturing review: neither a lot history review nor a device history record (dhr) review could be performed as the lot number was not provided.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.Investigation summary: one tri-funnel 20f cat#000720 was returned for evaluation.Visual and functional testing were performed.The balloon appeared to inflate asymmetrically.However, after further evaluation from the manufacturing site, the asymmetry was found to be within the acceptable specs for this product.The investigation is unconfirmed for the alleged asymmetry due to the device being within the allowable limits for this device.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.

Event Description

It was reported that during preparation, the feeding device balloon allegedly inflated asymmetrically.There was no reported patient involvement.

• Brand Name: TRI-FUNNEL REPL GAST 20F
• Type of Device: FEEDING
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9174939
• MDR Text Key: 164436681
• Report Number: 3006260740-2019-02977
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741037153
• UDI-Public: (01)00801741037153
• Combination Product (y/n): N
• PMA/PMN Number: K063118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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: 08/09/2019
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1