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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that nutrition leaked at the location of the purple connector.The issue occurred during priming.Patient was not involved.
Additional Manufacturer Narrative
Additional information h2, h3, h4, h6 investigation conclusion the customer reported that nutrition leaked at the location of the purple connector (video attached).The issue occurred during priming.The patient was not involved; therefore, no patient injury, medical intervention, or adverse reaction was associated with this event.The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.The reported product was not returned for evaluation as it was discarded by the customer; however, a video clip was provided.Examination of the video clip confirmed the reported product failure as a leak was identified at the cross-spike connection.A formal investigation has been initiated to determine the root cause of the confirmed product failure.This complaint will be used for 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
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11988023
• Report Number: 1282497-2021-10268
• Device Sequence Number: 11619448
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: Health Professional
• Device Model Number: 672055
• Device Catalogue Number: 672055
• Device Lot Number: 200410125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown