MAUDE Adverse Event Report: COVIDIEN EPUMP 1000ML SAFETY SCREW SPIK; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 775100

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested but at this time, no further details have been provided.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 Description

The customer reported that four feed/flush sets tubing's were leaking.It was leaking between the purple spike and the connection between the tubing.

Manufacturer Narrative

Submit date: 18-apr-2019.Additional information received on 9-apr-2019 stated that no patient was involved.Based off this, section h6 patient was updated.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was release accomplishing all quality standards.Upon a visual and functional evaluation of the samples, the defect was confirmed; leaking was detected between the connection of the tubing line and the cross spike connector.As part of continuous improvements, a corrective action has been opened which includes assembly process changes.These actions are designed to prevent the reoccurrence of the reported defective condition.This complaint will be used for qa tracking and trending purposes.

• Brand Name: EPUMP 1000ML SAFETY SCREW SPIK
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 8482429
• MDR Text Key: 140915326
• Report Number: 1282497-2019-08363
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 190180177
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1