MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN NASOGASTRIC TUBE; DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/18/2023

Event Type  Injury  

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.Root cause could not be determined.All information reasonably known as of 20-dec-2023 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.H3 other text: device not returned.

Event Description

Avanos medical received a single report that referenced nine different incidences, which were associated with separate units, involving nine different patients.This is the fourth of nine reports.Refer to 3011270181-2023-00141 for the first event.Refer to 3011270181-2023-00142 for the second event.Refer to 3011270181-2023-00143 for the third event.Refer to 3011270181-2023-00145 for the fifth event.Refer to 3011270181-2023-00146 for the sixth event.Refer to 3011270181-2023-00147 for the seventh event.Refer to 3011270181-2023-00148 for the eighth event.Refer to 3011270181-2023-00149 for the ninth event.It was reported a neoconnect nasogastric tube was in use on a patient.The patient developed necrotizing enterocolitis (nec) or spontaneous intestinal perforation (sip).At present the patient is reportedly deceased.The cause of nec, sip, and death are unknown at this time.Additional information has been requested.

Event Description

Additional information received 01-feb-2024 stating the user "facility's findings of their assessment of the infants affected by necrotizing fasciitis (nec) in their nicu on (b)(6) 2024.The facility swabbed and cultured the ng (nasogastric) tubes and gastric/intestinal content of the infants affected, and conclusively found no evidence the cases of nec were caused by avanos' ng tubes." the patient had normal abdominal flora and no indications the ng tube was the cause of the nec.Additional information received 04-feb-2024 stated the patient was receiving prolacta feeding solution.The patient had a penrose drain placed at the bedside on (b)(6) 2023.The patient died without additional intervention, an exploratory laparotomy was declined by the parents, compassionate care was initiated.

Manufacturer Narrative

All information reasonably known as of 27-feb-2024 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: UNKNOWN NASOGASTRIC TUBE
• Type of Device: DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT)
• 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 rd; tourism resort; dongqian lake, ningbo zhejiang
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18368543
• MDR Text Key: 331048103
• Report Number: 3011270181-2023-00144
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 25 DA
• Patient Race: White