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

Model Number	000716
Medical Device Problem Codes	Burst Container or Vessel (1074); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 catheter allegedly fell out of the patient.Reportedly, there was a narrow gap between the stomach wall and the abdominal wall.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: the sample returned for evaluation was one 16 fr tri-funnel replacement gastrostomy feeding tube.Visual, functional, and microscopic evaluations were performed of the physical sample.The sample was returned with a longitudinally-aligned c-shaped split in the balloon material.The surrounding material near the split site had a distended shape memory and dark usage discoloration.The observed damage is consistent with a burst due to over-pressurization.Therefore, the investigation is unconfirmed for 2923e - feeding tube dislodged and confirmed for 1074a - balloon ruptured.The investigation indicates that the failure is resulting from balloon rupture, and while a definitive root cause could not be determined based upon available information, procedural issues may have contributed to this event.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, possible complications and contraindications showed that the product labeling is adequate.(expiry date: 06/2021).
Event or Problem Description
It was reported that the catheter allegedly fell out of the patient.Reportedly, there was a narrow gap between the stomach wall and the abdominal wall.There was no reported patient injury.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 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: 7659220
• Report Number: 3006260740-2018-01595
• Device Sequence Number: 16187030
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: NGCN0404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1