MAUDE Adverse Event Report: BD BD INTEGRA SYRINGE 3ML 25G X1; SYRINGE, PISTON

Lot Number 1081330

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/16/2021

Event Type  malfunction  

Event Description

[bd integra syringe 3ml 25gx1] use for covid-19 under emergency use authorization (eua): bd integra syringe.During administration the contents of the syringe came out from the side of the syringe where the needle and syringe is connected.Fda safety report id # (b)(4).

• Brand Name: BD INTEGRA SYRINGE 3ML 25G X1
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD ; franklin lakes NJ 07417
• MDR Report Key: 12202277
• MDR Text Key: 262880048
• Report Number: MW5102629
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1081330
• 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