MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 2.4CM; TUBE, GASTRO-ENTEROSTOMY

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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, as the device was discarded after the event occurred.A lot history review (lhr) of huay2394 showed no 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) 2017, lasted less than one month and began leaking.The mother stated that if she uses the "old" tubing she has had at home the button does not leak.When using the "new" tubing it appears the leak is coming from the tube and not the button.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 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.Traces of residue were observed within the button device, which showed that the product had been used.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.A buildup of feeding material and damage from a decompression tube may have caused the valve to gape open.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.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.A lot history review (lhr) of huay2394 showed no 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) 2017, lasted less than one month and began leaking.The mother stated that if she uses the "old" tubing she has had at home the button does not leak.When using the "new" tubing it appears the leak is coming from the tube and not the button.No patient injury was reported.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 2.4CM
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6747330
• Report Number: 3006260740-2017-01148
• Device Sequence Number: 821260
• 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): 09/26/2017

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 Expiration Date: 11/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 000286
• Device Lot Number: HUAY2394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1