MAUDE Adverse Event Report: COVIDIEN KANGAROO PEDIATRIC FEEDING TUB; ENTERAL FEEDING TUBE

Model Number 460711E

Device Problem Malposition of Device (2616)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Manufacturer Narrative

Submit date: 8/30/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on 8/22/2016 that an adverse event occurred with enteral feeding tube.The customer reports the rn inserted this feeding tube via l nare on (b)(6) infant.Tube taped at 21 cm per measurement, placement verified by auscultating small amount of air and aspirated small amount of blood.After rn fed infant via ngt, the patient developed increasing respiratory distress.Xray revealed the feeding tube had been passed through the trachea, not the esophagus, and the feeding tube had perforated the left lung of the baby and was behind the stomach.The day of the incident the patient had 2 chest tubes and was placed on a ventilator and transferred to a higher level of care.

Manufacturer Narrative

Submit date: 09/20/2016.Originally reported: "it was reported to covidien on (b)(6) 2016 that an adverse event occurred with enteral feeding tube.The customer reports the rn inserted this feeding tube via l nare on (b)(6) newborn infant.Tube taped at 21cm per measurement, placement verified by auscultating small amount of air and aspirated small amount of blood.After rn fed infant via ngt, the patient developed increasing respiratory distress.X-ray revealed the feeding tube had been passed through the trachea, not the esophagus, and the feeding tube had perforated the left lung of the baby and was behind the stomach.The day of the incident the patient had 2 chest tubes and was placed on a ventilator and transferred to a higher level of care." it has been updated to: "it was reported to covidien on (b)(6) 2016 that an adverse event occurred with enteral feeding tube.The customer reports an estimated 36-38 weeks gestational age baby boy born via caesarian section due to breech presentation weighing (b)(6) was brought to the nicu post-delivery due to respiratory distress.Rn inserted feeding tube into the left nare, tube taped at 21cm per measurement, placement verified by auscultating small amount of air and aspirated small amount of blood.After rn administered 10 ml of feeds via gravity through the ng (nasogastric) tube the patient developed increasing respiratory distress.Patient was intubated and chest x-ray revealed the feeding tube had been passed through the trachea, not the esophagus, and the feeding tube had perforated the left lung of the baby and was behind the stomach.Chest tube placement x2 and transfer of patient to higher level of care.Approximately, 5-7 days post incident current patient's condition was assessed.Patient had to have new chest tubes place surgically and patient was extubated and placed on hfnc (high flow nasal cannula).Patient has since left the hospital and condition unknown.".

Event Description

It was reported to covidien on (b)(6) 2016 that an adverse event occurred with enteral feeding tube.The customer reports an estimated 36-38 weeks gestational age baby boy born via caesarian section due to breech presentation weighing (b)(6) was brought to the nicu post-delivery due to respiratory distress.Rn inserted feeding tube into the left nare, tube taped at 21cm per measurement, placement verified by auscultating small amount of air and aspirated small amount of blood.After rn administered 10 ml of feeds via gravity through the ng (nasogastric) tube the patient developed increasing respiratory distress.Patient was intubated and chest x-ray revealed the feeding tube had been passed through the trachea, not the esophagus, and the feeding tube had perforated the left lung of the baby and was behind the stomach.Chest tube placement x2 and transfer of patient to higher level of care.Approximately, 5-7 days post incident current patient's condition was assessed.Patient had to have new chest tubes place surgically and patient was extubated and placed on hfnc (high flow nasal cannula).Patient has since left the hospital and condition unknown.

Manufacturer Narrative

Submit date: 12/02/2016.Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

Manufacturer Narrative

The device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.One decontaminated sample was received for evaluation.During the examination of the sample, it was confirmed that the product complied with all quality requirements.The analysis performed by the multi-functional reveals the failure mode could not be confirmed, therefore the root cause was not identified.The personnel involved in the manufacturing process were notified about the reported condition.The manufacturing process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: KANGAROO PEDIATRIC FEEDING TUB
• Type of Device: ENTERAL FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana 92173 ; MX 92173
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5913933
• MDR Text Key: 53484306
• Report Number: 9612030-2016-00413
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 460711E
• Device Catalogue Number: 460711E
• Device Lot Number: 614519364X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention