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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MAGELL INSULIN 1/2ML 29GX1/2; SYRINGE, PISTON
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COVIDIEN MAGELL INSULIN 1/2ML 29GX1/2; SYRINGE, PISTON Back to Search Results
Model Number 8881892950
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 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 that the magellan insulin needle flipped out of the safety cap causing a needle stick.
 
Additional Manufacturer Narrative
Correction: initial reporter information corrected.
 
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Brand Name
MAGELL INSULIN 1/2ML 29GX1/2
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key8897249
Report Number1915484-2019-01078
Device Sequence Number1617292
Product Code FMF
UDI-Device Identifier10884521005945
UDI-Public10884521005945
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/11/2019
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 Number8881892950
Device Catalogue Number8881892950
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/13/2019
Supplement Date Received by Manufacturer08/13/2019
Initial Report FDA Received Date08/15/2019
Supplement Report FDA Received Date09/11/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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