MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 14F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000714
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
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 not provided, a review of the device history records could not be 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 allegedly the feeding tube unintentionally dislodged from the patient.It was reported that the balloon ruptured and leaked.There was no reported patient injury.
Additional Manufacturer Narrative
Complete manufacturing review could not be conducted for the investigation as the lot number is unknown.One 14 fr tri-funnel repl gastrostomy feeding tube was returned for evaluation.Functional, tactile, visual, microscopic, and measurement evaluations were performed.The investigation is confirmed for the reported deflation, as a 3 mm partially circumferential crack at the proximal end of the membrane attachment was found.Leaking occurred through the crack when the inflation lumen was infused.Magnification showed evidence of tearing and a relatively rough sharp edged granular surface at this crack.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event; the damage to the balloon evidently occurred during use but the cause is unknown.A review of baw0732741, rev.2 was performed, however, the cause of this event is unknown and therefore the appropriate section in the ifu, if any, is uncertain.If manufacturing related, a review of product labeling documents is not applicable.Product labeling, such as indications, warnings, precautions, cautions, possible complications, and contraindications, would not have prevented this issue.
Event or Problem Description
It was reported that allegedly the feeding tube unintentionally dislodged from the patient.It was reported that the balloon ruptured and leaked.There was no reported patient injury.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 14F
• 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: 7768048
• Report Number: 3006260740-2018-01997
• Device Sequence Number: 19345428
• Product Code: KNT
• UDI-Device Identifier: 00801741037122
• UDI-Public: (01)00801741037122
• 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): 12/10/2018

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: 000714
• Device Catalogue Number: 000714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1