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

Model Number 000720

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 01/2022).

Event Description

It was reported that during use of the feeding tube device, the balloon was allegedly punctured.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a lot history review was completed, which identified that this is the first complaint record for this lot number.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 20 fr tri-funnel was returned for evaluation.Visual, microscopic and functional testing were performed.A complete circumferential break was noted approximately 7.6cm from the proximal end of the tri-funnel.A rupture was noted on the balloon approximately 1.7cm proximal to the distal tip.Blood and residue were noted throughout.Packaging and label were not returned.Sample was decontaminated.The investigation is confirmed for the punctured balloon leading to a leak of the inflating medium (water).The cut to the shaft of the tube appears to have been done by a sharp instrument.The definitive root cause could not be determined based upon the available information.

Event Description

It was reported that during use of the feeding tube device, the balloon was allegedly punctured.There was no reported patient injury.

• Brand Name: TRI-FUNNEL REPL GAST 20F
• Type of Device: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9257340
• MDR Text Key: 164408769
• Report Number: 3006260740-2019-03400
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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: NGCT4157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 95 YR