MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE; FEEDING DEVICE

Model Number	000718
Medical Device Problem Codes	Inflation Problem (1310); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was not provided, therefore, the device history records were not reviewed.The device has been return to the manufacturer.The investigation is currently under way.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 a peg tube allegedly fell out of placement and the balloon was deflated.A new device was placed.It was further reported that there was no harm to the patient.
Additional Manufacturer Narrative
Manufacturing review: complete manufacturing review could not be conducted for the investigation as the lot number is unknown.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.Investigation summary: the device received was one 18 fr tri-funnel repl gastrostomy feeding tube.Functional, visual, and tactual evaluations were performed.No leaks were found in the catheter/balloon and no deflation was noted over time.The investigation is unconfirmed for the reported deflation issue, as the event was not reproduced in the lab setting, but the complaint of catheter dislodgment is inconclusive because certain clinical conditions not reproducible in the lab may reasonably have contributed to this event.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.For example, insufficient inflation/frequency of balloon water replacement and use of air to inflate the balloon instead of water may cause dislodgement of the balloon.
Event or Problem Description
It was reported that a peg tube allegedly fell out of placement and the balloon was deflated.A new device was placed.It was further reported that there was no harm to the patient.

• Brand Name: TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7543285
• Report Number: 3006260740-2018-01111
• Device Sequence Number: 16747390
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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: Health Professional
• Device Model Number: 000718
• Device Catalogue Number: 000718
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 05/24/2018
• 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