MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR 18F; TUBE, GASTRO-ENTEROSTOMY

Model Number	000256
Medical Device Problem Codes	Failure to Infuse (2340); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.
Event or Problem Description
It was reported that the patient's extension tube on her button is bent.It will not allow formula to go in, but does allow water to pass freely.The device was replaced.There was no reported patient injury.
Event or Problem Description
It was reported that the patient's extension tubing on the button feeding device was allegedly bent.It was further reported that this bend did not allow formula feeding to pass though; however it allowed water to pass without complication.Reportedly, the feeding device was replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged button extension tube bent and unable to infuse as no objective evidence has been provided to confirm any alleged deficiency.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.

• Brand Name: BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR 18F
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7524515
• Report Number: 3006260740-2018-01008
• Device Sequence Number: 13877284
• Product Code: KGC
• UDI-Device Identifier: 00801741080821
• UDI-Public: (01)00801741080821
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

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 Model Number: 000256
• Device Catalogue Number: 000257
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 41