MAUDE Adverse Event Report: COVIDIEN 12FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461243E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that they had an unfortunate incident with an nj tube placement using the kangaroo iris.During insertion on the night shift, the patient experienced a pneumothorax and required a chest tube placement.The iris feeding tube was properly connected to the console at the time of placement.According to the customer's records, the nurse was not previously trained or certified to place iris tubes per their competency requirements.The nurse did not stop at the 30cm to visualize any of the anatomy (trachea, carina) but did consult with another unit rn who apparently was checked off.The patient was already intubated at the time of the event.It is unknown if the patient had any known respiratory abnormalities.This event occurred in the (b)(6).

• Brand Name: 12FR 43 IRIS FEEDING TUBE ENF
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12392297
• Report Number: 1282497-2021-10580
• Device Sequence Number: 4081753
• Product Code: PIF
• UDI-Device Identifier: 20884521742229
• UDI-Public: 20884521742229
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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: 461243E
• Device Catalogue Number: 461243E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/31/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention