12FR 43 IRIS FEEDING TUBE ENF
Received Aug 31, 2021 · Event occurred Aug 11, 2021
Report 1282497-2021-10580 · MDR key 12392297
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pneumothorax
- Pneumothorax
Narrative
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.
Description of Event or Problem
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).