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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 25X5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN
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COVIDIEN MAGELLAN 3ML SFTY COMBO 25X5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number 8881833558
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event or Problem Description
The customer reported the needle was not fully tightened on the syringe and it was not checked before using the syringe/needle.The medication squirted out around the connection.There was no patient harm.
 
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Brand Name
MAGELLAN 3ML SFTY COMBO 25X5/8
Common Device Name
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
COVIDIEN
2010 east international speedw
deland FL 32724
MDR Report Key10534618
Report Number1017768-2020-00865
Device Sequence Number3734847
Product Code FMI
UDI-Device Identifier10884521005846
UDI-Public10884521005846
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number8881833558
Device Catalogue Number8881833558
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/20/2020
Initial Report FDA Received Date09/15/2020
Patient Sequence Number1
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