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

Model Number	000718
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 000718 replacement gastronomy tube allegedly experienced a deflation issue.This information was received from one source.The malfunction involved a patient without consequence.The involved patient was reported to be female without age or weight provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 000718 replacement gastronomy tube allegedly experienced a deflation issue.This information was received from one source.The malfunction involved a patient without consequence.The involved patient was reported to be female without age or weight provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction is unknown, therefore the manufacturing review could not be conducted.The device has been returned for evaluation; the evaluation could not confirm a deflation issue.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: through a communication with the u.S.Food and drug administration on 09/16/2019, it was identified that the procode knt is no longer eligible for voluntary malfunction summary reporting (vmsr).However, the initial emdr was previously submitted in the prior quarter when the procode was eligible for vmsr.Therefore, this report is the supplemental to the initial report.H10: g4 h11: h6 (method, results, conclusion) h11:section a through f - the information provided by bd 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 bd.

• Brand Name: TRI-FUNNEL
• Common Device Name: REPLACEMENT GASTROSTOMY TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8827820
• Report Number: 3006260740-2019-02198
• Device Sequence Number: 2510551
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: No Information
• Device Model Number: 000718
• Device Catalogue Number: 000718
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1