MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 3.4CM; TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 huye1993 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (huye1993) have been reported from the same (b)(4) facility.Device not yet returned for evaluation.
Event or Problem Description
It was reported that the bard button was stressed and broke off into the patient's stomach.It was stated that the hospital advised contact that it would come out in his bowel movements but that has yet to be seen.The patient is taking liquid called iso which seems to be working well for patient.This report addresses event three.
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 cause could not be determined.The proximal end of a 24fr 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 shaft and button dome were not returned for investigation.A microscopic examination of the button shaft revealed that approximately one quarter of the cross section exhibited what appear to be beach marks that originated from the side with the strap and plug.It appears that the tear developed over time.The remainder of the cross section was uneven, but smooth and granular.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 the external bolster exceeds material strength.
Event or Problem Description
It was reported that the bard button was stressed and broke off into the patient's stomach.It was stated that the hospital advised contact that it would come out in his bowel movements but that has yet to be seen.The patient is taking liquid called iso which seems to be working well for patient.This report addresses event three.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 24F X 3.4CM
• 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: 6664928
• Report Number: 3006260740-2017-00913
• Device Sequence Number: 16658918
• Product Code: KGC
• UDI-Device Identifier: 10801741087902
• UDI-Public: (01)10801741087902(17)170630(10)HUYE1993
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/25/2017

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: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 000287
• Device Lot Number: HUYE1993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1