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	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 is pending return 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 balloon component of a feeding catheter allegedly ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device returned was one 14 fr tri-funnel repl gastrostomy feeding tube.The complaint of ruptured balloon is confirmed.Visual, microscopic and functional testing was performed.The results of the evaluation indicated a nearly longitudinal split in the balloon near the center, with a granular break surface, curling of the edges of the break, and stretching of the material.The material was bunched up in the region of the burst.The complaint of a balloon rupture is confirmed.While a definitive root cause could not be determined based upon available information, a likely cause of burst in this device is overpressurization due to overfill during use.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.The ifu (pk0732741, rev.2) states: ¿check balloon volume every 7 to 10 days for correct inflation volume using the following steps: discontinue feeding.Use a luer-tip syringe to completely evacuate water from balloon.Discard evacuated water.Reinflate balloon with appropriate amount of water.Maximum inflation volume is printed on the color-coded balloon inflation port.¿ ¿¿do not exceed the maximum recommended inflation volume¿¿.
Event or Problem Description
It was reported that the balloon component of a feeding catheter allegedly ruptured.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: 7539343
• Report Number: 3006260740-2018-01069
• Device Sequence Number: 1775081
• Product Code: KNT
• UDI-Device Identifier: 00801741037122
• UDI-Public: (01)00801741037122
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

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: Lay User/Patient
• Device Model Number: 000714
• Device Catalogue Number: 000714
• Device Lot Number: NGAV1538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR