MAUDE Adverse Event Report: AVANOS MEDICAL INC. PFTM6.5V-EO PVC FEEDING TUBE PURP 6.5FR 60CM; DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED

Model Number	PFTM6.5V-EO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 15-oct-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported the nasogastric (ng) tube was placed on (b)(6) 2020.On (b)(6) 2020, the patient was taken to exploratory surgery, "because his bowels are short and he doesn't tolerate the feeds," and they found a broken part of an ng tube in his intestine, the physician stated it, "had been in there for quite a while." the patient's family member stated the patient is, "doing fine," at present.Additionally, the family member stated the patient has a tube, "in his belly, but the nurse told [me] that he would have to have an ng tube.".

• Brand Name: PFTM6.5V-EO PVC FEEDING TUBE PURP 6.5FR 60CM
• Common Device Name: DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10683234
• Report Number: 3011270181-2020-00120
• Device Sequence Number: 13529167
• Product Code: KNT
• UDI-Device Identifier: 00817584012615
• UDI-Public: 00817584012615
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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: Lay User/Patient
• Device Model Number: PFTM6.5V-EO
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/15/2020
• Patient Sequence Number: 1
• Patient Age: 2 MO