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

Model Number UNKNOWN ENTERAL FEEDING

Device Problem Air/Gas in Device (4062)

Patient Problem Vomiting (2144)

Event Type  malfunction  

Manufacturer Narrative

Product id was not provided, the udi could not be identified at this time.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 during the time of using the kangaroo feeding pump, her daughter experienced frequent vomiting, which with their medical team, were not able to diagnose the problem.The customer further stated that there was an excess air that was being pumped into her daughter¿s little body.

• Brand Name: UNKNOWN ENTERAL FEEDING
• Type of Device: PUMP, INFUSION, ENTERAL
• 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: 11698177
• MDR Text Key: 246486302
• Report Number: 1282497-2021-10082
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN ENTERAL FEEDING
• Device Catalogue Number: UNKNOWN ENTERAL FEEDING
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2021
• Type of Device Usage: N
• Patient Sequence Number: 1