MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 4.4CM TUBE, GASTRO-ENTEROSTOMY

Model Number 000296

Device Problem Migration or Expulsion of Device (1395)

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

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) of huzf0233 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported on (b)(4) 2017 that the dome migrated out of the stomach within the first few months after insertion. There was no reported patient injury.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 4.4CM
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7042863
• MDR Text Key: 93139452
• Report Number: 3006260740-2017-02077
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10801741087933
• UDI-Public: (01)10801741087933
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K904779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 000296
• Device Catalogue Number: 000296
• Device Lot Number: HUZF0233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial