MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY 1 COUNT OF 3ML BD LUER-LOK SYRINGE WITH NEEDLE 22G X 1.5"; SYRINGE, PISTON

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Event Description

One (1) count of 3ml bd syringe luer lock with needle 22g x 1.5:"treatment under emergency use authorization (eua): 1 crooked plunger.Fda safety report id # (b)(4).

• Brand Name: 1 COUNT OF 3ML BD LUER-LOK SYRINGE WITH NEEDLE 22G X 1.5"
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY
• MDR Report Key: 11482209
• MDR Text Key: 240059010
• Report Number: MW5099976
• Device Sequence Number: 1
• Product Code: FMF
• 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: 03/10/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2021
• 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