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U.S. Department of Health and Human Services

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

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COVIDIEN KANG EPUMP PROX SPIKE SET-INTL; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 674655
Device Problem Air/Gas in Device (4062)
Patient Problems Nausea (1970); Vomiting (2144); Discomfort (2330); Abdominal Distention (2601)
Event Date 12/08/2020
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.
 
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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 Key11012971
MDR Text Key221759818
Report Number1282497-2020-09788
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521028203
UDI-Public10884521028203
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/15/2020
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 Number674655
Device Catalogue Number674655
Device Lot Number192100100
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/11/2020
Initial Date FDA Received12/15/2020
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
Patient Age7
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