MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH MAGELLAN 3 ML SYRINGE WITH HYPODERMIC SAFETLY NEEDLE 25 G X 1" BY COVIDIEN; SYRINGE, PISTON

Lot Number 033553

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/15/2021

Event Type  malfunction  

Event Description

Magellan syringe with needle; treatment under emergency use authorization(eua): magellen 3 ml syringe with hypodermic safety needle.25 g x 1" the vaccination came out the connector of needle and syringe when giving a covid vaccination.Ran down patient's arm.Both were secure and tight.It happened to a 2 people by covidien.Fda safety report id# (b)(4).

• Brand Name: MAGELLAN 3 ML SYRINGE WITH HYPODERMIC SAFETLY NEEDLE 25 G X 1" BY COVIDIEN
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH ; mansfield MA 02048
• MDR Report Key: 11528034
• MDR Text Key: 241425942
• Report Number: MW5100103
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/15/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 033553
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR