MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 3.4CM; BUTTONS/WIZARD

Model Number	000287
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of huaq2174 showed no other similar product complaint(s) from this lot number.The device has yet to be returned for evaluation.
Event or Problem Description
It was reported that the patient had the button form less than 60 days.The fissure at the base of the cap resulted in extravasation of diet or any other solution when injected.When the device was removed the withdrawal cap of the button fractured completely and did not resist the necessary pressure that the procedure required resulting in light bleeding in the ostomy.
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 tear in the button replacement device was confirmed, but the exact mechanism of damage was undetermined.One 24f x 3.4cm button replacement device was returned for investigation.There was a complete tear in the button shaft at the distal surface of the external bolster.The external bolster and strap were not returned for investigation.The proximal end of the tube was uneven.A portion of the cross section was uneven, but smooth and granular.A portion of the cross section exhibited striations that resembled beach marks.It appeared that the tear developed over time.The device exhibited evidence of use.At this time, based on the condition of the returned sample, it appears that the damage occurred during use, but the exact mechanism of damage could not be determined.Potential contributing factors include tension on and manipulation of the external bolster.A lot history review (lhr) of huaq2174 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patient had the button form less than 60 days.The fissure at the base of the cap resulted in extravasation of diet or any other solution when injected.When the device was removed the withdrawal cap of the button fractured completely and did not resist the necessary pressure that the procedure required resulting in light bleeding in the ostomy.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 3.4CM
• Common Device Name: BUTTONS/WIZARD
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6866682
• Report Number: 3006260740-2017-01620
• Device Sequence Number: 1222092
• Product Code: KGC
• UDI-Device Identifier: 10801741087902
• UDI-Public: (01)10801741087902
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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 Expiration Date: 03/28/2019
• Device Model Number: 000287
• Device Catalogue Number: 000287
• Device Lot Number: HUAQ2174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 60