MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 2.4CM; TUBE, GASTRO-ENTEROSTOMY

Model Number	000283
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the facility, via ms&s, that the dietician has a patient with a button whose mom wants a feeding extension.The dietician found an extension, but the mom wants one shorter, which she can't find anything like this on the website.The mom states "it pops out" and needs to know if there is anything to secure the extension into the button.Ms&s provided her with the product information and told her that if the extension tube pops out, it is possible the device has been stretched out over time or it is possible the air/gas could push it out.Ms&s told her that if it is air or gas then using a decompression tube may help.Ms&s inquired when the tube pops out, is it at random times or when the patient is active or sleeping? ms&s also inquired as to how long the button device has been placed.The mother stated she did not know how long the button device has been in, but she thinks it is less than one year.The mother also stated that the doctor changed the patient's previous tube and replaced it with a button because "the mom was not happy with the previous tube".Ms&s provided the dietician the product numbers and descriptions and suggested that the patient's mom could also call ms&s if she has any questions about the button.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 2.4CM
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6742420
• Report Number: 3006260740-2017-01123
• Device Sequence Number: 1063446
• Product Code: KGC
• UDI-Device Identifier: 10801741087865
• UDI-Public: (01)10801741087865
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Dietician
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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
• 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: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1