MAUDE Adverse Event Report: COVIDIEN MAGELLAN INSULIN 1ML 29GX1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881892910
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested but to date, no further details have been provided.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 stated that a staff member experienced a needle stick after he injected a covid patient with insulin.The staff member used the safety but it did not click in all the way.The staff member thought he had heard the click.The staff member went to ohs in the morning.

• 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 Key: 11248120
• Report Number: 1915484-2021-01205
• Device Sequence Number: 3977404
• Product Code: FMI
• UDI-Device Identifier: 10884521005938
• UDI-Public: 10884521005938
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2021

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 Number: 8881892910
• Device Catalogue Number: 8881892910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 01/28/2021
• Patient Sequence Number: 1