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

Model Number	000716
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
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 8 days after placement the balloon deflated, allegedly due to a pinhole or a tear.Reportedly the catheter fell out of the patient.It was stated that prior to placement a pretest had been completed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history record has been reviewed, and during review of the manufacturing process for the balloon there was no manufacturing related cause found for the reported event.Investigation summary: the device returned was one 16 fr tri-funnel repl gastrostomy feeding tube.The device showed signs of use.Visual, microscopic, tactile, and functional testing were performed.The balloon had a burst near the center and the balloon membrane showed stretch marks and evidence of tearing with a relatively rough surface and sharp edges.There was abundant delamination of layers of the balloon material and significant material stretching immediately around the burst.The complaint of a deflation of the balloon is confirmed and found more specifically to be due to a balloon burst.The complaint of a balloon rupture is confirmed, 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 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 8 days after placement the balloon deflated, allegedly due to a pinhole or a tear.Reportedly the catheter fell out of the patient.It was stated that prior to placement a pretest had been completed.The device was removed and a new device placed.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: 7648290
• Report Number: 3006260740-2018-01519
• Device Sequence Number: 13490825
• 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): 10/15/2018

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: 000716
• Device Catalogue Number: 000716
• Device Lot Number: NGBW1822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 10/13/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1