MAUDE Adverse Event Report: COVIDIEN EPUMP FEED AND 1000MLFLUSH SET; PUMP, INFUSION, ENTERAL

Model Number	773662
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
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 consumer called in to report that the feeding sets do not stay connected with his feeding tube.The feeding set disconnects causing leaking.There was no harm to the patient.
Additional Manufacturer Narrative
The customers wife reported he husbands feeding sets do not stay connected with the feeding tube.There was no patient injury/harm 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.A trend review of the reported lot number and failure mode performed did not identify any related trends.One (1) used device was returned for evaluation.Visual inspection performed determined the sample was incomplete/inadequate for evaluation; therefore, functional evaluation was unable to be performed.The reported issue was unable to be confirmed and a root cause was not determined.Additional action will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11656672
• Report Number: 1282497-2021-10049
• Device Sequence Number: 3449223
• Product Code: LZH
• UDI-Device Identifier: 30884521022106
• UDI-Public: 30884521022106
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 210180050
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/28/2021
• Patient Sequence Number: 1