MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 18F; FEEDING DEVICE

Model Number	000718
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation, however, video was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2022).
Event or Problem Description
It was reported that approximately sixteen days post feeding tube placement, the balloon allegedly leak from the entrance when the balloon is inflated.Reportedly, the another device was replaced.There was no reported patient injury.
Event or Problem Description
It was reported that approximately sixteen days post feeding tube placement, the balloon allegedly leak from the entrance when the balloon is inflated.Reportedly, another device was replaced.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: per the complaint history review, this is the first complaint reported for this lot number.A device history record review is not required.Investigation summary: the sample was not returned for evaluation, however, two electronic photos and one electronic video were provided for review.The investigation is confirmed for reported fluid leak issue as the video appears to show that water comes out of the valve after the syringe is removed suggesting the valve is broken.A definitive root cause for the reported failure could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 01/2022), g4 h11: h6 (results, conclusion) h11:section a through f - the information provided by bd 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 bd.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 18F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10269339
• Report Number: 3006260740-2020-02411
• Device Sequence Number: 14292521
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: Other
• Device Model Number: 000718
• Device Catalogue Number: 000718
• Device Lot Number: NGCW1776
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 40