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

Model Number	674655
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144); Discomfort (2330); Abdominal Distention (2601)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11012971
• Report Number: 1282497-2020-09788
• Device Sequence Number: 3814033
• Product Code: LZH
• UDI-Device Identifier: 10884521028203
• UDI-Public: 10884521028203
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 674655
• Device Catalogue Number: 674655
• Device Lot Number: 192100100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/15/2020
• Patient Sequence Number: 1
• Patient Age: 7