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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the connector of the product is not compatible with the nasogastric feeding tube they are using.Due to the problem with the connectors, they are experiencing a problem of food dripping on the patient's bed.
Additional Manufacturer Narrative
Investigation results: the customer reported the connector of the device is not compatible with the nasogastric feeding tube they are using.Due to the problem with the connectors, they are experiencing a problem of food dripping on the patient's bed.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.Product lot and failure mode trend analysis did not identify a trend within the reported lot, nor for the reported failure mode.The customer provided two videos.Visual inspection of the videos identified the incorrect adapter was being used to connect the kangaroo bag.The reported device was returned for evaluation.Visual inspection and functional testing were performed and no failure was found.The root case of this report was determined to be use error as the device was used with the incorrect adapter.Additionally, a connection adapter test was performed an no failure was found.The reported failure is not confirmed and additional action will not be taken at this time.This reported failure mode will continue to be monitored and trended.

• 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: 11210731
• Report Number: 1282497-2021-09863
• Device Sequence Number: 17109085
• Product Code: LZH
• UDI-Device Identifier: 10884521028197
• UDI-Public: 10884521028197
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 193290053
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 04/23/2021
• Patient Sequence Number: 1