MAUDE Adverse Event Report: COVIDIEN 777401 EPUMP ENPLUS SPIKE SET X30; PUMP, INFUSION, ENTERAL

Model Number 777401

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2019

Event Type  malfunction  

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.

Event Description

The customer reported that the epump tube has broken inside the pump while the nurse was rinsing the nasogastric probe.Additional information received from the customer stated that the tube broke into two pieces and leaked.

Manufacturer Narrative

Evaluation summary no device history record (dhr) review could be completed as no lot number details were available.During routine production, tensile testing is performed on the junction between the mistic connector and the silicone tubing for all sub-assemblies.One (1) used sample was returned and visual inspection confirmed that the silicone tubing is disconnected from the mistic connector on the sample.Functional tests cannot be carried out on the sample as it is contaminated with food.The manufacturing site has opened a corrective and preventative action (capa) to further investigate this report and to implement effective solutions to prevent reoccurrence of this issue.As there was no lot number provided with the complaint, the site cannot say if the lot was manufactured prior to the corrective actions implemented as part of the capa.The associated data will be fed into the risk management quarterly report and this complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Section e1 has been updated to correct the initial reporter's first, middle, and last name along with their email address.Their phone number is unknown, the phone number previously listed should be disregarded.

• Brand Name: 777401 EPUMP ENPLUS SPIKE SET X30
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 9328770
• MDR Text Key: 168049550
• Report Number: 9611018-2019-00361
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2020

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
• Device Operator: No Information
• Device Model Number: 777401
• Device Catalogue Number: 777401
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 11/13/2019; 11/13/2019
• Supplement Dates FDA Received: 01/15/2020; 03/09/2020
• Patient Sequence Number: 1