MAUDE Adverse Event Report: COVIDIEN 12FR 55 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461255E
Medical Device Problem Codes	Obstruction of Flow (2423); Separation Failure (2547)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that in the early morning, they went in to give the patient some meds via nasojejunal tube.Flushed tube with 30 ml.Then as soon as they went to give meds, crushed and mixed well with about 40ml of water, the tube immediately clogged.It was then noticed that the tube still had the guide wire in the tube.It is unclear why the guide wire was left in tube even after placement was verified and tube feedings were started.Whatever they tried, the tube would not unclog.They attempted to remove the wire and it would only come out part way and then the tube would coil and irritated and caused pain for patient.Team notified; keofeed replaced endoscopically under general anesthesia.
Additional Manufacturer Narrative
Section b5 has been updated to include: "additional information provided by the customer on december 14, 2020 stated that the rn utilized the keofeed with the guidewire in place because she assumed that the correct port was visible and she lacked the knowledge of the product which was new to them.It is unknown if there were any kinks in the tubing.The patient required the anesthesia to replace the keofeed and had to have an endoscopy to have the keofeed removed and have a peg placed.The keofeed could not be placed at bedside (typical practice) the following day due to the pain, irritation, and lack of rom.The patient eventually required peg tube placement for nutrition but this was unrelated to the event".Section h6 "type of investigation" has been updated.Additional information provided by the customer stated that the device has been discarded.
Event or Problem Description
The customer reported that in the early morning, they went in to give the patient some meds via nasojejunal tube.Flushed tube with 30 ml.Then as soon as they went to give meds, crushed and mixed well with about 40ml of water, the tube immediately clogged.It was then noticed that the tube still had the guide wire in the tube.It is unclear why the guide wire was left in tube even after placement was verified and tube feedings were started.Whatever they tried, the tube would not unclog.They attempted to remove the wire and it would only come out part way and then the tube would coil and irritated and caused pain for patient.Team notified; keofeed replaced endoscopically under general anesthesia.Additional information provided by the customer on december 14, 2020 stated that the rn utilized the keofeed with the guidewire in place because she assumed that the correct port was visible and she lacked the knowledge of the product which was new to them.It is unknown if there were any kinks in the tubing.The patient required the anesthesia to replace the keofeed and had to have an endoscopy to have the keofeed removed and have a peg placed.The keofeed could not be placed at bedside (typical practice) the following day due to the pain, irritation, and lack of rom.The patient eventually required peg tube placement for nutrition but this was unrelated to the event.

• Brand Name: 12FR 55 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: 10972107
• Report Number: 1282497-2020-09767
• Device Sequence Number: 17217090
• Product Code: PIF
• UDI-Device Identifier: 20884521742236
• UDI-Public: 20884521742236
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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?: Yes
• Operator of Device: No Information
• Device Model Number: 461255E
• Device Catalogue Number: 461255E
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 12/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR