MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 14F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000714
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation; as the device was discarded at medicon due to expire of stock period after visual inspection.A lot history review (lhr) of ngzf4517 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (ngzf4517) have been reported from three (b)(6) facilities.Discarded at medicon due to the expire of stock period after visual inspection.
Event or Problem Description
It was reported that before doing an inflation test of the device and before inserting it into the patient, the operator could not inflate it completely.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 14F
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6811100
• Report Number: 3006260740-2017-01378
• Device Sequence Number: 138941
• Product Code: KNT
• UDI-Device Identifier: 00801741037122
• UDI-Public: (01)00801741037122
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 000714
• Device Catalogue Number: 000714
• Device Lot Number: NGZF4517
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1