MAUDE Adverse Event Report: COVIDIEN CONNECT FEED STE 1000ML NS; PUMP, INFUSION, ENTERAL

Model Number 77100FD

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

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

Event Date 04/01/2021

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 they found the feeding set tubing on the floor.The set came apart from the welded connection that goes into the cassette causing leaking.

Manufacturer Narrative

Additional information: h2, h3, h6.Investigation summary: the customer reported the tubing disconnected automatically and leaked.There was no patient injury/harm reported.The device history record (dhr) review was unable to be performed as the reported lot number was unknown.One used device was received for evaluation.Visual inspection of the device confirmed the report of disconnection/detachment as the pvc tubing was found disconnected from the cassette.The root cause of this confirmed product failure was traced to the pvc tubing extrusion process as the tubing diameter is not within specification, causing detachment at the cassette and tubing connection point.An investigation was initiated and a corrective action has been completed for the extrusion process (tubing line).At this time, no further action is necessary.This complaint will be used for tracking and trending purposes.

• Brand Name: CONNECT FEED STE 1000ML NS
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11666880
• MDR Text Key: 245490188
• Report Number: 1282497-2021-10055
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521190825
• UDI-Public: 10884521190825
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 77100FD
• Device Catalogue Number: 77100FD
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2021
• Patient Sequence Number: 1