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

Model Number	672055
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; 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 when priming the set had air inside and it was unable to prime.The machine was changed but the problem persisted.The set was changed and they were able to continue with the therapy.The operator of the product involved was a healthcare professional.Customer has confirmed that actual sample is not available for evaluation, sample was discarded by the customer.There are no companion samples to be returned.There are no other deficient products used during the event.There was no patient involvement, no patient injury, medical intervention or adverse reaction is associated with this event.

• 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: 11335671
• Report Number: 1282497-2021-09917
• Device Sequence Number: 19110545
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

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: 200410123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 02/16/2021
• Patient Sequence Number: 1