MAUDE Adverse Event Report: AVANOS MEDICAL INC. ENFIT PU FEEDING TUBE PURP 5FR 60CM; DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED)

Model Number	PFTM5.0P-NC
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced a stomach perforation.Additional information received 25-oct-2021 stated the og (oral gastric) was initially placed on (b)(6) 2021 at 01:59am.The bedside rn (registered nurse) charted the abdomen was pink and distended, on (b)(6) 2021 at 04:00am the nnp (neonatal nurse practioner) was notified.A cxr (chest x-ray) including abdomen was performed on (b)(6) 2021 at 05:30am which showed pneumoperitoneum and the distal tip of the og tube was extending beyond the gastric bubble.A "vygon tube" was placed, the patient was to be npo (no feedings after 03:00am) and zosyn medication was started on (b)(6) 2021 at 06:00am.The patient was transported to a children's medical center for surgical management on (b)(6) 2021 at 09:10am.The patient's current status was unknown as of 25-oct-2021.No additional information has been provided on the status on the patient.
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 12-nov-2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.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).

• Brand Name: ENFIT PU FEEDING TUBE PURP 5FR 60CM
• Common Device Name: DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): NINGBO TIANYI MEDICAL APPLIANCE CO, LTD; no. 788, mozhi north road; tourism resort, dongqian lake; ningbo, zhejiang 31512 1; CH 315121
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12828875
• Report Number: 3011270181-2021-00055
• Device Sequence Number: 1521128
• Product Code: FPD
• UDI-Device Identifier: 00350770001760
• UDI-Public: 00350770001760
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K082238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PFTM5.0P-NC
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VYGON TUBE; ZOSYN
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 4 DA
• Patient Sex: Female