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

Model Number 775100

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

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 silicone part of the set that goes into the pump broke and came off during the infusion of the diet causing the set to leak.There was no patient injury.

Manufacturer Narrative

Investigation summary: the customer reported the silicone part of the set that goes into the pump broke and came off during the infusion of the diet causing the set to leak.There was no patient injury/harm reported.The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.A lot and failure mode trend review performed did not identify related trends.One (1) used sample was returned for evaluation.Visual inspection identified feed in the line.Functional testing was unable to be performed as the feed had hardened within the line; therefore, the report of detached component/leak is not confirmed.Additional actions are not required at this time as the reported product issue was no confirmed and the manufacturing review completed for the product lot determined product specifications were met.This product report 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: 11325044
• MDR Text Key: 232398245
• Report Number: 1282497-2021-09910
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 201530057
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/09/2021
• Patient Sequence Number: 1