MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM; BUTTONS/WIZARD

Catalog Number	000282
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
Per ms&s, patient's mother called and wanted to confirm how big the internal bolster is for the 18fr 1.7cm bard button.She stated this button was in place for over one year, but during the removal process the shaft broke away from the external portion of the button.The shaft and internal bolster are inside the stomach.Ms&s stated that the widest portion of this internal bolster is 0.56".Ms&s explained that she would need to report it to fa, but when asked for her contact information, she was not willing to share it.She stated "she would have the doctor call", then hung up.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM
• Common Device Name: BUTTONS/WIZARD
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5349395
• Report Number: 3006260740-2015-00625
• Device Sequence Number: 16159759
• Product Code: KGC
• UDI-Device Identifier: 10801741087858
• UDI-Public: (01)10801741087858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Patient
• Report Date (Section B): 12/17/2015

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: Lay User/Patient
• Device Catalogue Number: 000282
• Device Lot Number: REQUESTED, NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1