MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BUTTON 18F; BUTTONS/WIZARD

Catalog Number	000282
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2017
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that in (b)(6) 2017, a bard button was inserted in the patient to change his/her existing gastronomy feeding tube.The day after the insertion, the patient returned due to an alleged leak from the central hole.Reportedly the leak was observed from the central hole post feeding of milk.It was reported that the stopper did not fit properly.No reported harm to patient.
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 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 from the button feeding tube was inconclusive due to the sample condition.One photograph was the only item provided for investigation.What appears to be the external bolster and strap of a bard button device was shown.The button device was shown in the stoma of a patient.The strap and plug were not closed.Instead, what appears to be the 90-degree white plastic part of the feeding tube was in the button device.An arrow pointing to the 90-degree adaptor is labeled with the text, ¿temporary stopper created by us and have been used for the past 1 month.¿ an arrow pointing to the button strap and plug is labeled with the text, ¿leaking from the hold due to stopper doesn¿t fit properly ? hole too big ?stopper too small¿.The inner diameter (id) of the hole in the button device and the outside diameter (od) of the plug could not be measured since the physical sample was not returned for investigation.The complaint was therefore inconclusive.
Event or Problem Description
It was reported that in (b)(6) 2017, a bard button was inserted in the patient to change his/her existing gastronomy feeding tube.The day after the insertion, the patient returned due to an alleged leak from the central hole.Reportedly the leak was observed from the central hole post feeding of milk.It was reported that the stopper did not fit properly.No reported harm to patient.

• Brand Name: BUTTON 18F
• Common Device Name: BUTTONS/WIZARD
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6508348
• Report Number: 3006260740-2017-00491
• Device Sequence Number: 1201953
• Product Code: KGC
• UDI-Device Identifier: 10801741087858
• UDI-Public: (01)10801741087858
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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 Catalogue Number: 000282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1