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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 25X1; NEEDLE, HYPODERMIC, SINGLE LUMEN
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COVIDIEN MAGELLAN 3ML SFTY COMBO 25X1; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number 8881833510
Medical Device Problem Code Fail-Safe Problem (2936)
Health Effect - Clinical Code Needle Stick/Puncture (2462)
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The customer stated that the medical assistant was following the manufacturer guidelines of engaging the safety device on the needle by sliding the needle on hard surfaces.The contaminated needle bent back and stuck the ma on the left thumb.The needle should have closed safely to prevent a contaminated needle sticks as shown in the guidelines.
 
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Brand Name
MAGELLAN 3ML SFTY COMBO 25X1
Common Device Name
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
COVIDIEN
2010 east international speedw
deland FL 32724
MDR Report Key11932818
Report Number1017768-2021-00945
Device Sequence Number14248554
Product Code FMI
UDI-Device Identifier10884521005839
UDI-Public10884521005839
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number8881833510
Device Catalogue Number8881833510
Device Lot Number902844
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/27/2021
Initial Report FDA Received Date06/03/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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