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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN 3ML SFTY COMBO 23X1; NEEDLE, HYPODERMIC, SINGLE LUMEN
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CARDINAL HEALTH MAGELLAN 3ML SFTY COMBO 23X1; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number 8881833310
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 03/24/2021
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. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event or Problem Description
Customer reported that a dose of covid-19 vaccine was wasted due to the leak on the side of the syringe.
 
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Brand Name
MAGELLAN 3ML SFTY COMBO 23X1
Common Device Name
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
CARDINAL HEALTH
2010 east international speedw
deland FL 32724
MDR Report Key12348622
Report Number1017768-2021-00972
Device Sequence Number19854164
Product Code FMI
UDI-Device Identifier10884521005815
UDI-Public10884521005815
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/20/2021
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 Number8881833310
Device Catalogue Number8881833310
Device Lot Number034941
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/18/2021
Initial Report FDA Received Date08/20/2021
Patient Sequence Number1
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