Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MAGELLAN INSULIN 1ML 29GX1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN MAGELLAN INSULIN 1ML 29GX1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number 8881892910
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
Customer reports: there was a needle stick caused from the safety device not activating.Additional information provided by the customer stated that the nurse was stuck by the needle after she had administered a insulin vaccination.The nurse had to undergo lab testing as a result of the needle stick and the tests results are pending.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAGELLAN INSULIN 1ML 29GX1/2
Common Device Name
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key11866687
Report Number1915484-2021-01247
Device Sequence Number3725217
Product Code FMI
UDI-Device Identifier10884521005938
UDI-Public10884521005938
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/21/2021
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 Number8881892910
Device Catalogue Number8881892910
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/14/2021
Initial Report FDA Received Date05/21/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-