MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 16F; ENTERAL FEEDING

Model Number	000716
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was originally determined to be a malfunction reportable event on (b)(6) 2019 and reported to the fda through the quarterly voluntary malfunction summary reporting (vmsr) program.Bdpi received a notification from the fda on 9/16/2019 stating that the procode knt is ineligible for the vmsr program; therefore, the mdr date of awareness was modified to reflect the date of the fda notification of procode ineligibility.Manufacturing review: a lot history record review could not be completed as the lot number was not provided.Investigation summary: one 16 fr tri-funnel device was returned for evaluation.Visual and functional evaluations were performed.The investigation is confirmed for a leak, specifically a leaky valve.Functional testing initially found no issues when the balloon was inflated with 20 cc of water, but upon re-inflation the inflation port began to leak.The position of the valve stem was not centered within the valve, but leaning to one side.The top face of the valve was visible.In addition, one electronic photo was reviewed.The photo shows an entire tri-funnel device with orange inflation hub with ¿20cc inflation¿ thereon.The bolster was at approximately the 6-cm depth mark, and the balloon appeared deflated, with no more than slight discoloration visible.Although a leak was confirmed, a definitive root cause could not be determined, such actions as the insertion of a foreign object or improper syringe into valve, leading to valve failure/malposition, could cause a leak such as that observed from the valve.This may be consistent with the report that leakage occurred after infusion of fluid after placement.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that post gastrostomy feeding tube placement the device was filled with sterilized water and allegedly leaked.Reportedly, the device was removed.There was no reported patient injury.

• Brand Name: TRI-FUNNEL REPL GAST 16F
• Common Device Name: ENTERAL FEEDING
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9169858
• Report Number: 3006260740-2019-02945
• Device Sequence Number: 2811156
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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: 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: 07/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1