MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 3.4CM; BUTTONS/WIZARD

Model Number N/A

Device Problems Leak/Splash (1354); Sticking (1597)

Patient Problem No Code Available (3191)

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 for evaluation, as the device remains in the patient.A lot history review (lhr) of hubt1736 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the patient that she had a g-tube placed on friday, (b)(6) 2017 to replace her prior peg tube.She stated that when the port flips open to attach the tube, bile spills out.Medical services & support informed the patient that there is a valve that sometimes becomes stuck, allowing stomach contents to leak through.Ms&s gave the patient verbal instructions on how to use the decompression tube to decompress the stomach and also to replace the valve into the correct position.Patient was also advised to contact physician.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 3.4CM
• Type of Device: BUTTONS/WIZARD
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6959567
• MDR Text Key: 90662225
• Report Number: 3006260740-2017-01848
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10801741087872
• UDI-Public: (01)10801741087872
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 000284
• Device Lot Number: HUBT1736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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
• Patient Age: 44 YR