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U.S. Department of Health and Human Services

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

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COVIDIEN / CARDINAL HEALTH MAGELLAN 3 ML SYRINGE WITH HYPODERMIC SAFETLY NEEDLE 25 G X 1" BY COVIDIEN SYRINGE, PISTON Back to Search Results
Lot Number 033553
Device Problems Break (1069); Fluid 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).
 
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Brand NameMAGELLAN 3 ML SYRINGE WITH HYPODERMIC SAFETLY NEEDLE 25 G X 1" BY COVIDIEN
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN / CARDINAL HEALTH
mansfield MA 02048
MDR Report Key11528034
MDR Text Key241425942
Report NumberMW5100103
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number033553
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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