MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BUTTON 18F; TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000282
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 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
It was reported that the patient had the 18fr, 1.7 cm tube- low profile gastronomy button.The patient¿s mother noted leaking through the ¿skin hole¿, but then noted the leak occurred through the ¿lid¿, even when closed.This was the initial button exchange.No patient injury 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 from the button replacement device was confirmed.The damage observed on the device, which allowed fluid to leak, appeared to be supplier/manufacturing related.One 18fr x 1.7cm button replacement device was returned for investigation.A functional test confirmed the alleged leak.The functional test at the manufacturing facility could not replicate the leak, which may indicate that the leak is affected by the position of the plug.A microscopic examination of the plug revealed damage from what appeared to be a combination of a tear and deformation, which created a fluid path and allowed fluid in the button stem to bypass the sealing features of the plug.The complaint sample was forwarded to the manufacturing facility for further review.The part is supplied from one bard facility to another bard facility.
Event or Problem Description
It was reported that the patient had the 18fr, 1.7 cm tube- low profile gastronomy button.The patient¿s mother noted leaking through the ¿skin hole¿, but then noted the leak occurred through the ¿lid¿, even when closed.This was the initial button exchange.No patient injury reported.

• Brand Name: BUTTON 18F
• Common Device Name: TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6393354
• Report Number: 3006260740-2017-00222
• Device Sequence Number: 10976182
• Product Code: KGC
• UDI-Device Identifier: 10801741087858
• UDI-Public: (01)10801741087858
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: 000282
• Device Catalogue Number: 000282
• Device Lot Number: HUZK0290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1