MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE,12F; FEEDING TUBE

Model Number 000712

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation; however, the video was provided for review.The investigation of the reported event is currently underway.Expiry date (09/2020).

Event Description

It was reported that the device allegedly had obstruction.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review:a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation, however, two electronic videos were provided for review.The investigation is confirmed for the reported obstruction of flow issue as issue is evident in the provided videos.A definitive root cause could not be determined based upon available information.Labeling review:a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.D4 (expiry date: 09/2020).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the device allegedly had obstruction.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE,12F
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10566431
• MDR Text Key: 207917416
• Report Number: 3006260740-2020-03318
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741037115
• UDI-Public: (01)00801741037115
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000712
• Device Catalogue Number: 000712
• Device Lot Number: NGBV3557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 MO