MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL

Model Number 775659

Device Problem Air/Gas in Device (4062)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the tubing is defective and it makes bubbles during a feed.It also appears that the tubing is pinched and causes feed errors.Per additional information received on 25-jul-2022, nothing was replaced.They we¿re just having problems with the wiring tube as it gets bubbles inside and blocks the machine.When they change it, sometimes it works, and sometimes they need to change it five times.There¿s a defect with the wiring tube itself.They have had the machine and formula checked and they are fine.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Photos were provided for review.Examining the pictures can detect a kink on the tube, and air bubbles along the tube.Two used samples were also received for evaluation.A visual and functional inspection was performed on the returned samples and no issues were found; the problem shown in the photos was not able to be duplicated on the physical samples.Based on the available information, a root cause could not be determined.A corrective and preventive action is not required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP SAFETY SCREW SPIKE SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15153321
• MDR Text Key: 304418556
• Report Number: 1282497-2022-10709
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155831
• UDI-Public: 10884521155831
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 775659
• Device Catalogue Number: 775659
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1