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

Model Number	000714
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2016
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 after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.The original sample was discarded at the facility.
Event or Problem Description
It was reported that the balloon ruptures were observed consecutively 8 times on the same patient during about 3 weeks.This report describes the 4th balloon rupture.The 14fr tube was inserted on (b)(6) 2016 and found to be removed spontaneously from the patient and ruptured on (b)(6) 2016.The device was used for the administration of the anticonvulsant to the patient.The medicines administrated were as follows: sodium valprorate 20%, zonisamide 100 mg, prosesiya tablet 20 mg, aspara potassium acid 50%, magmitt 330 mg.(tablets were crushed when it administered.).

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 14F
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6816396
• Report Number: 3006260740-2017-01401
• Device Sequence Number: 1430508
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2017

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 Model Number: 000714
• Device Catalogue Number: 000714
• 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: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1