MAUDE Adverse Event Report: BD BD SYRINGE; SYRINGE, PISTON

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

[moderna vaccine booster] use for covid-19 under emergency use authorization (eua): moderna covid 19 vaccine, pt claimed she got the shot too high in the arm so it injured her arm.Fda safety report id # (b)(4).

• Brand Name: BD SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 13560311
• MDR Text Key: 285931804
• Report Number: MW5107551
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White