MAUDE Adverse Event Report: COVIDIEN UNKNOWN ENTERAL FEEDING; PUMP, INFUSION, ENTERAL

Device Problem Fluid/Blood Leak (1250)

Patient Problem Burn(s) (1757)

Event Date 01/06/2020

Event Type  malfunction  

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 Description

The customer reported that the luer lock type connection that attaches to the gtube leaked both formula and potentially stomach acid from an unknown feeding set.The formula and potentially stomach acid were leaking on to the patient.Medical intervention via prescription cream was necessary because the patient had some burns.The customer further stated that the tubing did not seem to disconnect from the luer lock port, both pieces were still intact however the customer could not be certain if the enfit connection was secure on the patient's gtube.

• Brand Name: UNKNOWN ENTERAL FEEDING
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; 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: 9678556
• MDR Text Key: 178343138
• Report Number: 1282497-2020-08901
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/06/2020
• Type of Device Usage: N
• Patient Sequence Number: 1