MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 24F; FEEDING DEVICE

Model Number	000724
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will 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.Expiry date (06/2023).
Event or Problem Description
It was reported that two months post g-tube placement, the balloon allegedly broke.It was further reported that the g-tube was required to be removed.There was no reported patient injury.
Event or Problem Description
It was reported that approximately two months post gastrostomy tube placement, the balloon of the tube allegedly ruptured with sterilized water leak and leads to a dislodgement.Reportedly, the device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: a sample evaluation could not be performed, as the device was not returned.Therefore, the investigation is inconclusive for the reported fluid leak, break and device dislodgment or dislocated issue.A definite root cause could not be determined based upon 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: 06/2023).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: TRI-FUNNEL REPL GAST 24F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10007835
• Report Number: 3006260740-2020-01528
• Device Sequence Number: 2749833
• Product Code: KNT
• UDI-Device Identifier: 00801741037177
• UDI-Public: (01)00801741037177
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: Health Professional
• Device Model Number: 000724
• Device Catalogue Number: 000724
• Device Lot Number: NGDW1641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1