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

Model Number 775100

Device Problem Leak/Splash (1354)

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

Event Date 07/20/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.  since the sample was not provided for evaluation the reported condition could not be confirmed.The root cause and corrective actions could not be identified.This complaint will be closed with no further action.If a sample is received later, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

Event Description

The customer reported: the cross tip where you make the connection is releasing from the vial resulting in a leakage of the diet formula.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Four decontaminated samples were received at the manufacturing site for the investigation.Visual and functional evaluations could not be performed as the samples were received in a condition which made analysis impossible.As a result, the reported condition could not be confirmed.A root cause could not be determined as the reported issue was not confirmed.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa 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: 9197325
• MDR Text Key: 162477804
• Report Number: 1282497-2019-08716
• 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: 03/18/2020

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: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 190040058
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 03/18/2020
• Patient Sequence Number: 1