MAUDE Adverse Event Report: NEOMED, INC PVC ENTERAL FEEDING TUBE WITH ENFIT CONNECTOR, PURPLE 8FR X 40CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	PFTS8.0V-NC
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neomed became aware of user facility report # (b)(4) on 21 january 2019.Additional information was received 13 february 2019 which deemed this complaint reportable.User facility reported an allegation for the potentiality of an adverse event stating the reported stiffened characteristic observed in identified units could cause "damage to the fragile mucosa of a preterm baby's stomach or esophagus".Facility confirmed no adverse event had occurred.Neomed is in the process of working with the facility to obtain more information as well as our medical advisor.Complaint samples have been returned to neomed and evaluations are ongoing.
Event or Problem Description
When removing an enteral pvc feeding tube from the patient it was noted that the distal section of tubing had stiffened and was difficult to bend as compared to the section of the tubing out of the neonates body and as compared with a new unused feeding tube in the package.The clinical team also found an additional pvc tube removed later from another patient with this same stiffening characteristic.
Additional Manufacturer Narrative
No additional facilities have reported complaints identifying tube stiffness.The underlying root cause relevant to the reported event can not be conclusively determined.

• Brand Name: PVC ENTERAL FEEDING TUBE WITH ENFIT CONNECTOR, PURPLE 8FR X 40CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): NEOMED, INC; 100 londonderry court; suite 112; woodstock GA 30188
• MDR Report Key: 8425613
• Report Number: 3006520777-2019-00002
• Device Sequence Number: 1254183
• Product Code: KNT
• UDI-Device Identifier: 00817584011243
• UDI-Public: 0100817584011243172009061020170907
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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 Expiration Date: 09/06/2020
• Device Model Number: PFTS8.0V-NC
• Device Catalogue Number: PFTS8.0V-NC
• Device Lot Number: 20170907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/13/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 DA