MAUDE Adverse Event Report: COVIDIEN JOEY SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL

Model Number 765559

Device Problem Infusion or Flow Problem (2964)

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

Event Date 09/02/2021

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 a new tube feed line was primed and attached to a patient for feeding.After a few minutes of running, the pump began to alarm hold error.Air was noted in the line and they attempted to prime the line to extract the air but were unable to prime.There was no harm to the patient,.

• Brand Name: JOEY SAFETY SCREW SPIKE SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12468299
• MDR Text Key: 271292729
• Report Number: 1282497-2021-10615
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155824
• UDI-Public: 10884521155824
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 765559
• Device Catalogue Number: 765559
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/07/2021
• Type of Device Usage: N
• Patient Sequence Number: 1