MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD; TUBE, GASTRO-ENTEROSTOMY

Model Number 98433

Device Problems Leak/Splash (1354); Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problems Erythema (1840); Sleep Dysfunction (2517)

Event Date 01/10/2019

Event Type  malfunction  

Event Description

Cancer of nasopharynx on chemotherapy cisplatin and radiation therapy.Patient had a peg tube placed in abdomen in december.Patient asked to be seen today in radiation with complaint of abdominal dressing very wet covering the peg tube.I had the rn remove the dressing with the intent to redo it but when the rn removed the dressing the g-tube was sitting in the dressing completely out of the patient's stomach as the tube had come dislodged at some point.Patient sleeps on his abdomen at night.At one point the patient had 4, of what the physician who placed the 2 called tacks.They look like little buttons, but there are only 2 currently, one almost detached and the second one very secured to the abdomen.There were no other notable tubes there.Patient also has significant erythema around one of the areas.I am uncertain how the abdomen is going to look once that is removed.Patient has not been using the tube but primarily has been flushing it.Patient otherwise seemingly is tolerating treatment reasonably well.Plan is to reinsert feeding tube tomorrow.The next day the patient refused replacement of g-tube today as scheduled.Patient did not want it put back in due to placement interfering with sleep, etc.Provider had a long discussion with the patient about risks of not replacing as the patient is going through therapy and the patient was informed that if they change their mind at any time it could be rescheduled.All remaining buttons removed, clean dressing applied to site and patient instructed to keep covered.

• Brand Name: HALYARD
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8319830
• MDR Text Key: 135518621
• Report Number: 8319830
• Device Sequence Number: 1
• Product Code: KGC
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 98433
• Device Catalogue Number: 98433-03
• Device Lot Number: AA8232R10
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2019
• Event Location: Other
• Date Report to Manufacturer: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 73