MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. HYPODERMIC NEEDLE-PRO SYRINGE JELCO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Underdose (2542)

Event Date 01/04/2021

Event Type  malfunction  

Event Description

Syringe malfunction.Administering moderna vaccine.The syringe broke away from the needle and the vaccine squirted out and ran down the patient's arm.The needle stayed in the patient's arm and i had to pull it out.Fda safety report id # (b)(4).

• Brand Name: HYPODERMIC NEEDLE-PRO SYRINGE JELCO
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11169857
• MDR Text Key: 227076879
• Report Number: MW5098809
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR