MAUDE Adverse Event Report: COVIDIEN EPUMP 1000ML SAFETY SCREW SPIK; PUMP, INFUSION, ENTERAL

Model Number 775100

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 07/04/2019

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.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 the feeding sets are leaking and detaching where the purple connector and the tubing attach.There was no harm to the patient.

Manufacturer Narrative

H 3: evaluation summary: the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.Samples were received at the manufacturing plant for evaluation.All samples were received in their original package.Visual and functional evaluation was performed, and it was noticed the set were leaking and detaching at the connection between the cross spike and the tubing line.The reported failure mode was confirmed as 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: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8782439
• MDR Text Key: 150819830
• Report Number: 1282497-2019-08556
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155817
• UDI-Public: 10884521155817
• 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
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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: 182780179
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/04/2019
• Patient Sequence Number: 1