MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM; TUBE, GASTRO-ENTEROSTOMY

Model Number	000282
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/17/2018
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 by the patient's mother that his button cap came off his feeding tube.She stated that the nurse was there and her son was on the mat, the nurse closed the button, but it was still open and the tip was still in the hole.The patient's mother states that it opens all the time by itself and food comes out.The patient's mother also stated that when it was inserted it looks like it was stretched out and it is "so thin" and it is very uncomfortable for her son.The device was removed and was replaced with another manufacturers device.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 cap (plug) coming off the strap of the feeding tube is confirmed and the cause is unknown.Visual observation found the proximal portion of the device to be returned separate from and without the rest of the button device.The plug normally attached to the strap had separated from the strap at its base.The characteristics of the break surface at the distal end were consistent with damage from scissors or similar.Microscopic evaluation found the surfaces of the break between the plug and the strap were relatively smooth and had parallel lines throughout much of it.The orifice of the tubing where the plug would normally reside was noticeably deformed at one side.Measurements of the plug od and the proximal tube id were both within specification.However, sections of flash apparently exceeded specification.This flash will be addressed in file (b)(4).The device was sent to the manufacturing site for examination of this flash as well as for evidence that the deformation at the orifice and/or the plug detachment could be related to manufacturing.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 by the patient's mother that his button cap came off his feeding tube.She stated that the nurse was there and her son was on the mat, the nurse closed the button, but it was still open and the tip was still in the hole.The patient's mother states that it opens all the time by itself and food comes out.The patient's mother also stated that when it was inserted it looks like it was stretched out and it is "so thin" and it is very uncomfortable for her son.The device was removed and was replaced with another manufacturers device.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7360187
• Report Number: 3006260740-2018-00492
• Device Sequence Number: 13966469
• Product Code: KGC
• UDI-Device Identifier: 10801741087858
• UDI-Public: (01)10801741087858
• 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): 06/22/2018

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 Model Number: 000282
• Device Catalogue Number: 000282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1