MAUDE Adverse Event Report: COVIDIEN EPUMP INTL 1000ML FD AND FLUSH; PUMP, INFUSION, ENTERAL

Model Number	673662
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2021
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
Customer reports: during priming, the unit presented a nutrition leak at the bottom of the device.
Additional Manufacturer Narrative
Investigation summary: the customer reported during priming, the unit presented a nutrition leak at the bottom of the device.The report refers to product code 673662, epump int.1000ml feed&flush ns, with lot number 203070030.A 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 device was not returned for evaluation; however, a photograph was provided by the customer.Visual evaluation of the photograph was unable to confirm the report of leak.A root cause was unable to be found related to the manufacturing/product process.Additional action will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP INTL 1000ML FD AND FLUSH
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11842750
• Report Number: 1282497-2021-10208
• Device Sequence Number: 17242087
• Product Code: LZH
• UDI-Device Identifier: 10884521028197
• UDI-Public: 10884521028197
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 673662
• Device Catalogue Number: 673662
• Device Lot Number: 203070030
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/12/2021
• Patient Sequence Number: 1