MAUDE Adverse Event Report: COVIDIEN KANG EPUMP PROX SPIKE SET-INTL; PUMP, INFUSION, ENTERAL

Model Number 674655

Device Problem Air/Gas in Device (4062)

Patient Problems Nausea (1970); Vomiting (2144); Discomfort (2330); Abdominal Distention (2601)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the lancet tip enteral feeding team had a problem where there was air intake in the line of the feeding set during administration of the enteral diet.It was necessary to change the equipment to continue the administration of the diet as the air in the line caused the patient discomfort, considerable abdominal distention, nausea, and vomiting.When the feeding set was replaced with a set from another batch the problem was resolved.

• Brand Name: KANG EPUMP PROX SPIKE SET-INTL
• 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: 11120967
• MDR Text Key: 225305218
• Report Number: 1282497-2021-09832
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521028203
• UDI-Public: 10884521028203
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 674655
• Device Catalogue Number: 674655
• Device Lot Number: 192100100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2020
• Type of Device Usage: N
• Patient Sequence Number: 1