MAUDE Adverse Event Report: AVANOS MEDICAL, INC. NEOMED FEEDING TUBE WITH ENFIT CONNECTOR, 6.5FR X 90CM; TUBE, FEEDING

Model Number PFTL6.5P-NC

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2022

Event Type  malfunction  

Event Description

Neomed feeding tube with enfit connector 6.5fr, 90cm.Ng feeding tube ruptured while in use.The ruptured area was external to patient.Feeding was infusing at time of rupture, to diabetic patient on insulin pump.Noted that patient glucose was down trending on the continuous glucose monitor, despite feed infusing for approx.15 minutes.Infant also becoming restless.Noted that feeding had leaked onto bed from ruptured area of feeding tube.Ruptured feeding tube removed.Provider notified.New feeding tube placed.Of note, patient receives a special dietary formula with added enzymes, which infuses through ng tube q3hrs via infusion pump.Also of note, entire tubing appears stretched (larger in diameter) and feels much softer compared to the same tubing new from packaging.Placed & then removed 12 days later.Internal depth of tubing to patient: 22cm at nare.Ruptured area between 31cm-33cm (which was external to patient).There was no harm in this event.

• Brand Name: NEOMED FEEDING TUBE WITH ENFIT CONNECTOR, 6.5FR X 90CM
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 14166415
• MDR Text Key: 289738091
• Report Number: 14166415
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PFTL6.5P-NC
• Device Catalogue Number: REF: PFTL6.5P-NC
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2022
• Date Report to Manufacturer: 04/21/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 180 DA
• Patient Sex: Male