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

Model Number	000286
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of huat1462 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the patient's mother that her daughter's button began leaking due to an alleged valve breakdown and leaked of stomach acids.This button was originally placed on (b)(6) 2017 and had to be removed today(b)(6) 2017.No patient injury was reported.
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 a leak is confirmed; however the root cause is unknown.One 24 f button feeding device was returned for evaluation.An initial visual observation showed use residue throughout the device, especially on the outer surface of the device.The sample was patent to infusion and did not leak during aspiration, however, when the bolus was filled with water and the port faced downward, a dripping leak was observed from the valve.A microscopic observation revealed some use residue within the internal bolster and near the valve, but not underneath the valve.No damage was observed on the valve or the surface it contacts on the bolster.The wall of the bolster was removed and a small gap was observed between the valve and its contact point on the bolster, however no damage or residue was observed.The cause of the small gap between the valve and the bolster which allowed for leakage is unknown; however possible causes include valve deformation due to residue buildup or excessive/extended decompression tube insertion and material fatigue.A lot history review (lhr) of huat1462 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the patient's mother that her daughter's button began leaking due to an alleged valve breakdown and leaked of stomach acids.This button was originally placed on (b)(6) 2017 and had to be removed today (b)(6) 2017.No patient injury was reported.

• 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: 6918989
• Report Number: 3006260740-2017-01784
• Device Sequence Number: 19045595
• 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): 11/08/2017

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: Lay User/Patient
• Device Model Number: 000286
• Device Catalogue Number: 000286
• Device Lot Number: HUAT1462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Event Location: Home
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1