MAUDE Adverse Event Report: COVIDIEN MAGELLAN HYPODERMIC SAFETY NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	21G X 1-1/2"
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
After giving im injection, rn closed the safety cap of the 21g 1.5 needle.When doffing isolation gown the needle came through the end of the safety cap and punctured left bicep.Fda safety report id # (b)(4).

• Brand Name: MAGELLAN HYPODERMIC SAFETY NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10307520
• Report Number: MW5095647
• Device Sequence Number: 923139
• Product Code: FMI
• UDI-Device Identifier: 30884521000470
• UDI-Public: 0130884521000470
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 21G X 1-1/2"
• Device Lot Number: 833803
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other