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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 Codes Break (1069); Material Deformation (2976)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/24/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter name, address, and facility were not provided on the medwatch form, cardinal health received (mw5088496).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
The customer reported the tip of the syringe was broken and melted.
 
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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 Key8901272
Report Number1017768-2019-00667
Device Sequence Number16638770
Product Code FMI
UDI-Device Identifier10884521005846
UDI-Public10884521005846
Combination Product (Y/N)N
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) 08/16/2019
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
Device Lot Number907740
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/14/2019
Initial Report FDA Received Date08/16/2019
Patient Sequence Number1
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