MAUDE Adverse Event Report: BECTON DICKINSON LUER-LOK 1ML SYRINGE; SYRINGE, PISTON

Lot Number 0196715

Device Problem Contamination (1120)

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

Event Date 03/06/2021

Event Type  Injury  

Event Description

Pfizer -biontech covid-19 vaccine treatment under emergency use authorization(eua): while drawing up vaccine, debris in a syringe was noticed.The needle/syringe was immediately from the vaccine vial and the safety cap was placed on the syringe.The vaccine vial and other doses that had been obtained from that vial were inspected, all solution was clear, colorless, with no particles or debris in the vial or other syringes.Syringe: 1ml luer-lok syringe.Lot#: 0196715 (exp 2025-06-30) needle: 23g x 1.5 inches dps: duopross meditech corp.Lot#2009055 (exp: 2025-09-28).Fda safety report id# (b)(4).

• Brand Name: LUER-LOK 1ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 11494594
• MDR Text Key: 240343948
• Report Number: MW5099996
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/08/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0196715
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1