MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 16F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000716
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was not provided, a review of the device history records has not been performed.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that approximately seven days post feeding tube placement, the balloon allegedly deflated and a sterilized water leak was identified.Reportedly, the device was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number was not provided.Therefore, a lot history review could not be performed.Investigation summary: one tri-funnel 16f was returned for evaluation.Visual and functional testing were performed.The balloon was inflated with approximately 20ml of water and was allowed to sit for 10 minutes.The inflation of the balloon was imbalanced, with half the balloon being larger than the other half.The balloon was massaged and no leaks were noted.The balloon was deflated without issue.The investigation is unconfirmed for the alleged leaking of the balloon as it could not be reproduced in the laboratory setting.The definitive root cause could not be determined based upon available information.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.H10: g3, g4 h11: h3, h6 (results, conclusions) 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.
Event or Problem Description
It was reported that approximately seven days post feeding tube placement, the balloon allegedly deflated and a sterilized water leak was identified.Reportedly, the device was removed.There was no reported patient injury.

• Brand Name: TRI-FUNNEL REPL GAST 16F
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9818726
• Report Number: 3006260740-2020-00804
• Device Sequence Number: 3087097
• Product Code: KNT
• UDI-Device Identifier: 00801741037139
• UDI-Public: (01)00801741037139
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 000716
• Device Catalogue Number: 000716
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR