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

Model Number	000718
Medical Device Problem Codes	Deflation Problem (1149); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was not provided, therefore the device history records could not reviewed.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that approximately five days post feeding tube implant, the tube allegedly dislodged.There was no reported patient injury.
Event or Problem Description
It was reported that approximately five days post feeding tube implant, the tube allegedly dislodged.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: neither a lot history review nor a device history record (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 was returned for evaluation.Visual and microscopic evaluations were performed.Slight discoloration was noted around the balloon as well as striations on the surface of the balloon.There was a small hole noted amid the striation marks on the surface of the balloon.The investigation is confirmed for the observed hole on the balloon.One (1) electronic photo was reviewed.The photo shows the balloon portion of the feeding tube under a light and a small hole can be seen on the surface of the balloon.Striations on the surface can also be observed around the hole.The sample appears clean.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.

• Brand Name: TRI-FUNNEL REPL GAST 18F
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9251304
• Report Number: 3006260740-2019-03367
• Device Sequence Number: 2031055
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 10/21/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1