MAUDE Adverse Event Report: COVIDIEN KANG EPUMP 500ML PUMP SET-INTL; PUMP, INFUSION, ENTERAL

Model Number	672055
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.A sample was received at the manufacturing plant for evaluation.A visual and functional inspection was performed, and leaking was found between the bag and the line.The exact root cause could not be determined through the investigation.No formal investigation action is being taken because the failure mode is not a trend.This complaint will be closed with no further action.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported that 1 unit was broken at the beginning of the line.The event occurred during priming.There was patient involvement; but, no patient injury, medical intervention or adverse reaction.The sample received for investigation was found to have a leak between the bag and the line.

• Brand Name: KANG EPUMP 500ML PUMP SET-INTL
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10007320
• Report Number: 1282497-2020-09042
• Device Sequence Number: 19557449
• Product Code: LZH
• UDI-Device Identifier: 10884521028142
• UDI-Public: 10884521028142
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/28/2020

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: 672055
• Device Catalogue Number: 672055
• Device Lot Number: 192000052
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/28/2020
• Patient Sequence Number: 1