MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BUTTON 24F X 2.4CM; TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000286
Health Effect - Clinical Code	Burn(s) (1757)
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 huzg1090 showed (b)(4) other similar product complaint(s) from this lot number.
Event or Problem Description
The patients mother reported that the tubing/button that was placed in (b)(6) of 2017, lasted less than one month and began leaking.The patient has had burns on her stomach from the acid that is leaking from the tubing/button.The burn has healed and the patient is doing fine.The mother alleges that the button may be okay and the leak is from the "new" tubing.
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 through the button device was confirmed but the exact cause was undetermined.One 24fr x 2.4 cm button replacement device was returned for investigation.Residue remained adhered to the external surface of the button dome.An attempt to siphon water through the button device revealed that fluid could be drawn through the button valve.After removing the dome, a gap was visible between the valve and the bottom of the button shaft, which may have been a contributing factor in the reported event, but the exact cause of the gap or the leak was unknown.Particles of feeding material were observed in the valve.No fluid leaked from the button replacement device when the strap was closed.The product ifu indicates to close the safety plug to keep the lumen clean and to minimize reflux.The complaint sample was forwarded to the manufacturing facility for further review.A review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot.All units from this lot were 100% leak tested.The leak test includes a visual inspection to verify the valve is seated.No units from the lot were scrapped during the leak test.All complaints from this lot were reported by the same complainant.Per the manufacturing facility evaluation: one sample was received with a cream colored tone, and some residue adhered to the external surface of the button dome was observed.The valve was inspected using a magnifying lamp.The pinholes of the valve were found adhered to the pins of the stem, as required per the manufacturing procedure.A small gap was observed between the valve and the base of the button shaft (stem).The small gap between the valve and the stem is the most likely reason for the alleged leak, however it is unknown how this small gap occurred.Based on the investigation results, the valve must have been fully seated at the time that units were manufactured.Based on the sample received, the controls in place, and the investigation completed, the complaint is confirmed but could not be determined to being manufacturing related.
Event or Problem Description
The patients mother reported that the tubing/button that was placed in (b)(6) 2017, lasted less than one month and began leaking.The patient has had burns on her stomach from the acid that is leaking from the tubing/button.The burn has healed and the patient is doing fine.The mother alleges that the button may be okay and the leak is from the "new" tubing.

• Brand Name: BUTTON 24F X 2.4CM
• 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: 6746702
• Report Number: 3006260740-2017-01142
• Device Sequence Number: 1360884
• Product Code: KGC
• UDI-Device Identifier: 10801741087896
• UDI-Public: (01)10801741087896
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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: 07/31/2018
• Device Model Number: 000286
• Device Catalogue Number: 000286
• Device Lot Number: HUZG1090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Event Location: Home
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other