MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRI-FUNNEL REPL GAST 18F; FEEDING DEVICE

Model Number	000718
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was not provided, therefore, the device history records could not be reviewed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is underway.
Event or Problem Description
It was reported that some time post feeding tube implant, the balloon allegedly ruptured, resulting in the catheter falling out of the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: neither a lot history review nor a device history review (dhr) review could be performed as the lot number was not provided.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: one tri-funnel 18f cat#000718 was returned for evaluation.Visual and microscopic testing were performed.Blood and residue were noted throughout.A complete circumferential rupture with jagged edges was noted on the surface of the balloon leaving it unable to be inflated due to the balloon being rolled back toward the distal end of the device.The investigation is confirmed for the alleged rupture, because of the nature of the returned sample, the root cause of the rupture could not be assessed.The definitive root cause could not be determined based upon available information.It is unknown if clinical/manufacturing/shipping procedures issues contributed to the reported event.
Event or Problem Description
It was reported that approximately ten days post feeding tube implant, the balloon allegedly ruptured, resulting in the catheter falling out of the patient.There was no reported patient injury.

• Brand Name: TRI-FUNNEL REPL GAST 18F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9225835
• Report Number: 3006260740-2019-03305
• Device Sequence Number: 181757
• Product Code: KNT
• UDI-Device Identifier: 00801741037146
• UDI-Public: (01)00801741037146
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 000718
• Device Catalogue Number: 000718
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1