MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI FUNNEL 22F G-TUBE; REPLACEMENT G-TUBES

Catalog Number	000722
Health Effect - Clinical Code	Flatus (1865)
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 remains in the patient.A lot history review (lhr) of ngaz0963 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
As reported by the facility to ms&s, "caller states a patient with product 000722, 22fr tri-funnel gastrostomy tube is having issues with the tube popping open.Caller provided lot number ngaz0963.Response explained that one possible reason for the tube popping open can be because of gas pressure building up in the patient's stomach.Discussed occasionally opening the cap to allow gas to escape.Caller states she may have the doctor order some prevacid.".

• Brand Name: TRI FUNNEL 22F G-TUBE
• Common Device Name: REPLACEMENT G-TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6577211
• Report Number: 3006260740-2017-00651
• Device Sequence Number: 749816
• Product Code: KNT
• UDI-Device Identifier: 00801741037160
• UDI-Public: (01)00801741037160(17)190630(10)NGAZ0963
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

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: 06/30/2019
• Device Catalogue Number: 000722
• Device Lot Number: NGAZ0963
• 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: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1