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	03/04/2021
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 the connectors of the products are not compatible with the nasogastric feeding pump the customer is using.Due to the change of the connectors they are experiencing the problem of food dripping into the patient's bed.No patient injury was reported.Additional information received on 5-apr-2021 states that the ng tube that the customer uses is a polyurethane nutrition tube by bexen medical.Product number: 054.08, lot xs-1022.
Additional Manufacturer Narrative
Investigation summary: the customer reported the connectors of the products are not compatible with the nasogastric feeding pump the customer is using.Due to the change of the connectors, they are experiencing the problem of food dripping into the patient's bed.No patient injury was reported.The 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.Lot and failure mode trending was reviewed and no related trends were identified.One sample was received for evaluation.Visual inspection and functional testing performed was unable to confirm the reported issue as no fault was found.The device operated within specification and as intended.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: 11616673
• Report Number: 1282497-2021-10031
• Device Sequence Number: 19595345
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: 193290055
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 06/15/2021
• Patient Sequence Number: 1