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	Inflation Problem (1310)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
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 during placement procedure, the balloon was allegedly inflated asymmetrically, so the tube was unable to be implanted.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 14 fr tri-funnel replacement gastrostomy feeding tube.Visual, microscopic, and functional evaluations were performed of the physical sample.The sample's balloon was capable of inflating and aspirating, with no leaks observed.Inflation of the balloon revealed that the balloon appeared to be asymmetric - it inflated more on one side than on the other.The manufacturing site performed an evaluation of the sample, as follows: the complaint was confirmed as cause unknown for the reported issue (it was reported that during placement procedure, the balloon was allegedly inflated asymmetrically, so the tube was unable to be implanted.There was no reported patient injury.); per visual inspection evaluation no defects were noted.During functional evaluation the balloon was inflated with air using a syringe and no issues were found.The balloon was then inflated with 10cc with a mix of tap water and blue methylene using a syringe and then left to deflate on its own, it was noted that some water remain in the balloon and extra force was used to remove all the water.An asymmetrical balloon was observed, see image attached.The balloon was then cut to inspect the notch and no issues were found.By dimensional evaluation asymmetry was measured and found to be out of specification.Therefore, the investigation is confirmed for 1310f - balloon defective.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported 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.
Event or Problem Description
It was reported that during placement procedure, the balloon was allegedly inflated asymmetrically, so the tube was unable to be implanted.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: 7648603
• Report Number: 3006260740-2018-01529
• Device Sequence Number: 18871235
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 000714
• Device Catalogue Number: 000714
• Device Lot Number: NGBR1604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1