MAUDE Adverse Event Report: COVIDIEN EPUMP 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	772055
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested but has not yet been received.The incident sample has also 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.
Event or Problem Description
The customer reported that the enteral feeding set bag had a hole and leaked where the bag attaches to the tubing and this affected the feeding of the neonatal patient.
Additional Manufacturer Narrative
Section b5 was updated to reflect additional information received from the initial reporter on 31-may-2021.Based on the additional information received from the reporter, sections h6 health effect clinical code and health effect impact code were updated.
Event or Problem Description
The customer reported that the enteral feeding set bag had a hole and leaked where the bag attaches to the tubing and this affected the feeding of the neonatal patient.On (b)(6) 2021 the initial reporter stated it is not known how much formula leaked nor is it known how long the device was leaking for.No patient injury was reported.
Additional Manufacturer Narrative
Investigation summary: the customer reported the enteral feeding set bag had a hole and leaked where the bag attaches to the tubing.This product was used to feed a neonatal patient.A device history record (dhr) review was unable to be performed as the reported lot number was unknown.One (1) used device was returned for evaluation.Visual inspection and functional testing confirmed the report of leak as a small hole was identified in the bushing tube.The root cause of the confirmed product issue is related to the rf sealing machine process.A corrective action was taken to replace the rf sealing machine.This event will be used for tracking and trending purposes.

• Brand Name: EPUMP 500ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11467944
• Report Number: 1282497-2021-09965
• Device Sequence Number: 17124828
• Product Code: LZH
• UDI-Device Identifier: 10884521023925
• UDI-Public: 10884521023925
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2021

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: 772055
• Device Catalogue Number: 772055
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/04/2021; 03/04/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 06/04/2021; 06/23/2021
• Patient Sequence Number: 1