MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL

Model Number	383400
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device has been requested but to date has not been received for evaluation.If the device is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the device's flow was not conforming.Additional information was provided stating that the issue happened during reconditioning testing.The device flowed faster than the set rate.No further information was provided.

• Brand Name: KANGAROO JOEYPUMP W/POLE CLMP
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12454428
• Report Number: 1282497-2021-10605
• Device Sequence Number: 11778953
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/10/2021

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: No Information
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/10/2021
• Patient Sequence Number: 1