MAUDE Adverse Event Report: BECTON DICKINSON BD INTEGRA SYRINGE 3ML 25G X 1 (0.5MM X 25MM); SYRINGE, ANTISTICK

Catalog Number 305270

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2023

Event Type  malfunction  

Event Description

Defective syringe, bd integra syringe 3ml 25g x 1 (0.5mm x 25mm).Patient came into receive second dose of shingrix vaccine.Upon administration the vaccine expelled out where the needle attaches to the barrel of the syringe.The syringe was a bd integra syringe 3ml 25g x 1 (0.5mm x 25mm).

• Brand Name: BD INTEGRA SYRINGE 3ML 25G X 1 (0.5MM X 25MM)
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 17143414
• MDR Text Key: 317477191
• Report Number: MW5118426
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• 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: 06/14/2023

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
• Device Expiration Date: 01/30/2024
• Device Catalogue Number: 305270
• Device Lot Number: 0027028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White