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	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; 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. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that there was evidence of a nutrition leak in the set valve.There was patient involvement but not injury, medical intervention, or adverse reactions were associated with this event.
Additional Manufacturer Narrative
The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.No sample was received for the evaluation.The manufacturing site has received many pictures and a video for the analysis.Upon examination, air in the line was detected.Therefore, the reported condition is confirmed.The root cause and the action plan will be documented through a formal investigation.This complaint will be used for qa tracking and trending purposes.

• 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: 9912413
• Report Number: 1282497-2020-08992
• Device Sequence Number: 3272191
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/22/2020
• Patient Sequence Number: 1