MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 2.4CM; BUTTONS/WIZARD

Model Number 000283

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091)

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.A lot history review (lhr) of huzf0233 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (huzf0233) have been reported from the same facility.

Event Description

Per the reporting facility, the child's parents were caring for the device on discharge home after receiving education from the facility's team.The device was intact but had migrated out of the patient's stomach.This was discovered due to the child complaining of pain, the presence of swelling and redness at the insertion site, and the device was no longer sitting flush against the skin; the shaft of the device was visible and usually on an angle there is an obvious lump at the site.There was no complication as a result of this event.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 2.4CM
• 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: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 7068531
• MDR Text Key: 93631354
• Report Number: 3006260740-2017-02146
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10801741087865
• UDI-Public: (01)10801741087865
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000283
• Device Catalogue Number: 000283
• Device Lot Number: HUZF0233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Sequence Number: 1