MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 3.4CM; TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number N/A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

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 was discarded after the event occurred.A lot history review (lhr) of huye1993 showed (b)(4) other similar product complaint(s) from this lot number.The complaints for this lot number (huye1993) have been reported from the same (b)(4) facility.

Event Description

It was reported that the bard button was stressed and broke off into the patient's stomach.The device was removed and replaced.This report addresses event two.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 3.4CM
• Type of Device: TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 6664896
• MDR Text Key: 78465567
• Report Number: 3006260740-2017-00912
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10801741087902
• UDI-Public: (01)10801741087902(17)170630(10)HUYE1993
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K904779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/23/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 000287
• Device Lot Number: HUYE1993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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