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

Model Number	000283
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Swelling (2091)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BUTTONS/WIZARD
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7068531
• Report Number: 3006260740-2017-02146
• Device Sequence Number: 1357822
• Product Code: KGC
• UDI-Device Identifier: 10801741087865
• UDI-Public: (01)10801741087865
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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
• Operator of Device: Health Professional
• Device Model Number: 000283
• Device Catalogue Number: 000283
• Device Lot Number: HUZF0233
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1