MAUDE Adverse Event Report: COVIDIEN 10FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461043E

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  Injury  

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 Description

The customer reported that the camera component on the iris feeding tube broke off in a patient's nare.The bedside rn was able to remove the lodged camera at the bedside.No injury or discomfort to the patient was observed following the event.Additional information provided by the customer on 29-jan-2021 stated that the patient is an adult male with history of self-removal of his nasogastric feeding tubes; (b)(6) 2021 and (b)(6) 2021.A new kangaroo enteral feeding tube with iris technology, size 10fr, was inserted into the left nare and secured with an amt bridle nasal retaining device size 10fr by nccu nurse at 0950 on (b)(6) 2021.Prior to re-inserting the feeding tube, the nurse recalls noting a small about of dried brownish nasal mucous around the right nare, which the nurse removed.The nurse inserted the feeding tube and secured it with an amt bridle without difficulty nor distress to the patient.The nurse also recalls that she was able to visually identify the patient's internal anatomical landmarks during insertion and that placement was verified with x-ray prior to use.On the same day of insertion, the direct care nurse observed the feeding tube had been self-removed by the patient.The nurse reports recognizing that the tube tip was not intact and exposed wires could be seen.The patient did not appear to be in any distress and was not bleeding from either nare.The nurse consulted immediately with the neuro np.The neuro np reports examining the feeding tube, noting that is was not intact and proceeded to examine the patient's nares.The neuro np was able to visualize the feeding tube tip in the anterior left nare and easily removed it with gloved hands.The patient tolerated this removal with no signs of discomfort and no observable bleeding.They confirmed the amt bridle nasal securement device was intact; no other securement devices or tape were observed.

Manufacturer Narrative

A device history record review could not be performed because the serial number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One physical sample was received at our decontamination lab.However, the used sample could not be forwarded to the manufacturing site for physical evaluation due to current customs policies.As a result, photos were taken of the sample by the decontamination lab and provided to the manufacturing site to aid the investigation.Upon a visual evaluation of the photos, the reported issue was confirmed; a detached component was observed.The manufacturing process was reviewed.All tubes have passed 100% leakage testing per testing specifications.Tubes that do not pass this test are not packed or shipped.All tubes are also 100% inspected for any visual issues before packing.If any visual issues are observed, the tubes are not packed.In addition, a tensile test is completed on all tubes per requirement, and the results show that all tests have passed.Based on all available information, the root cause could not be determined at this time.However, if additional information becomes available or the sample is received by the manufacturing site, the investigation will be updated accordingly.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 tracking and trending purposes.

• Brand Name: 10FR 43 IRIS FEEDING TUBE ENF
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11269729
• MDR Text Key: 230042053
• Report Number: 1282497-2021-09883
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461043E
• Device Catalogue Number: 461043E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/26/2021
• Patient Sequence Number: 1