MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI FUNNEL 24F G-TUBE; REPLACEMENT G-TUBES

Model Number 000724

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2017

Event Type  malfunction  

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, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned, at this time.

Event Description

It was reported that water leaked, but the origin of the leak could not be specified.No patient harm reported.

Manufacturer Narrative

The initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred per 21 crf803.19.

Event Description

It was reported that water leaked, but the origin of the leak could not be specified.No patient harm reported.

• Brand Name: TRI FUNNEL 24F G-TUBE
• Type of Device: REPLACEMENT G-TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: michael new ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225445
• MDR Report Key: 6608107
• MDR Text Key: 76712085
• Report Number: 3006260740-2017-00719
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00801741037177
• UDI-Public: (01)00801741037177
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000724
• Device Catalogue Number: 000724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1