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

Model Number 775100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested but to date has not been received.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 reports that the tubing of the kangaroo epump enplus spike with flush bag leaks.

Manufacturer Narrative

Additional information: d 4 unique identifier added.H 3: evaluation summary.The device history record (dhr) review of the reported lot number shows no discrepancies.Samples were received at the manufacturing plant for evaluation.All samples were received in the original package.Visual and functional evaluation was performed, and detachment was noticed at the connection between the cross spike and the tubing line.The reported failure mode will be treated as confirmed, related to the manufacturing/production process.The root cause and action plan will be documented through a formal corrective and preventative action (capa).This complaint will be closed with no further action and will be used for 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: 8310320
• MDR Text Key: 135164550
• Report Number: 1282497-2019-08254
• 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
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• 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: 183480238
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1