MAUDE Adverse Event Report: COVIDIEN UNKNOWN ENTERAL ACCESS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number UNKNOWN ENTERAL ACCESS

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

According to the supplier, the device history record (dhr) could not be reviewed as the lot number/serial number was not provided by the customer.No photos or samples were provided therefore the issue reported could not be confirmed.According to the supplier, all iris feeding tubes go through a leak test with pressure of 20±0.1psi per customer test specification.Any tube blockage failure detected is held in the manufacturing line.All tubes released have passed the leak test before being packaged and shipped.No abnormalities were found on the manufacturing line in the last 12 months.Based on this investigation and all available information at this time, no abnormalities were found during the manufacturing process.Therefore, the root cause could not be determined.No actions will be taken for this time.If a sample or additional information is received at a later date, this investigation will be updated accordingly, and a follow up report will be submitted.This complaint will be used for tracking and trending purposes.

Event Description

The customer reported that an unknown iris feeding tube was placed.The patient was receiving medications that were being crushed and administered via keofeed.One week later the bedside nurse was not able to flush the medication port easily.The nurse attempted to use soda to address the clog but was unsuccessful.The keofeed was removed and a new one was re-inserted by nurse.The bedside nurse called the pharmacy to request medications be changed to oral solution and was advised that they could not be converted.The oral pills that are being crushed currently are: aspirin, aricept and midodrine.Additional information provided by the customer on 7-dec-2020 stated that formula was also unable to be delivered through the feeding tube.

• Brand Name: UNKNOWN ENTERAL ACCESS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10998206
• MDR Text Key: 226015874
• Report Number: 1282497-2020-09777
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN ENTERAL ACCESS
• Device Catalogue Number: UNKNOWN ENTERAL ACCESS
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/13/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR