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

Model Number	674655
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2021
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 they identified a large amount of air in the equipment, even when following the equipment placement guidelines with the pump turned off.The issue happened with 10 feeding sets from the same lot and were discarded.No patient injury was reported.

• Brand Name: KANG EPUMP PROX SPIKE SET-INTL
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11294712
• Report Number: 1282497-2021-09890
• Device Sequence Number: 19702752
• Product Code: LZH
• UDI-Device Identifier: 10884521028203
• UDI-Public: 10884521028203
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/08/2021

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: 674655
• Device Catalogue Number: 674655
• Device Lot Number: 202160319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/08/2021
• Patient Sequence Number: 1