MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 2.4CM; BUTTONS/WIZARD

Model Number	N/A
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of hubt1737 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that patient's button was placed on (b)(6) 2017.The button was placed without incident until this past week when it started leaking stomach acids.The button was removed and a new button placed (b)(6) 2017.Patients stomach is burned and is being treated with silvadene.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of leaking from the button device was inconclusive since the clinical conditions and complication could not be replicated.One 24fr x 2.4 cm button replacement device was returned for investigation.Residue remained adhered to the external surface the button device, which showed that the product had been used.The dome was removed from the button and the valve was noted to be sitting in its proper location.No reside was observed in the hinge area of the button valve.A functional test revealed that no liquid would leak from the button device.It was reported that the button was in place for over one month when it started leaking stomach acids.Although no leaks were observed in the returned button device, the complaint is inconclusive since the clinical conditions could not be replicated.
Event or Problem Description
It was reported that patient's button was placed on (b)(6) 2017.The button was placed without incident until this past week when it started leaking stomach acids.The button was removed and a new button placed (b)(6) 2017.Patients stomach is burned and is being treated with silvadene.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F 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: 7054027
• Report Number: 3006260740-2017-02118
• Device Sequence Number: 1301099
• Product Code: KGC
• UDI-Device Identifier: 10801741087896
• UDI-Public: (01)10801741087896
• Combination Product (Y/N): N
• 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: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 000286
• Device Lot Number: HUBT1737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Event Location: Home
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1