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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 Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/09/2020
Type of Reportable Event Malfunction
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 reported that there were fibers on the needle.
 
Additional Manufacturer Narrative
Section e1 has been updated to correct the initial reporter's first and last name which is (b)(6).
 
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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 Key9595687
Report Number1017768-2020-00775
Device Sequence Number18947018
Product Code FMI
UDI-Device Identifier10884521005839
UDI-Public10884521005839
Combination Product (Y/N)N
Initial Reporter StateCA
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,Followup
Report Date (Section B) 02/26/2020
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 Number8881833510
Device Catalogue Number8881833510
Device Lot Number826105
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 01/09/2020
Supplement Date Received by Manufacturer01/09/2020
Initial Report FDA Received Date01/16/2020
Supplement Report FDA Received Date02/26/2020
Patient Sequence Number1
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