MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD PLASTIPAK 3 ML 23G SYRINGE; SYRINGE, PISTON

Model Number DG510008

Device Problems Fluid/Blood Leak (1250); Structural Problem (2506)

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

Event Date 05/05/2021

Event Type  malfunction  

Event Description

[pfizer covid19 vaccine] use for covid-19 under emergency use authorization (eua): when drawing up 1.8 ml sodium chloride 0.9% to dilute pfizer covid19 vaccine, the 3 ml syringe being used to dilute vaccine vial malfunctioned when plunging to dilute and allowed sodium chloride to pass around the seal and into the barrel around the plunger.Fda safety report id# (b)(4).

• Brand Name: BD PLASTIPAK 3 ML 23G SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 11789713
• MDR Text Key: 249686214
• Report Number: MW5101210
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DG510008
• Device Lot Number: 0253054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1