MAUDE Adverse Event Report: BD BD INTEGRA 3ML SYRINGE AND RETRACTING NEEDLE; SYRINGE, ANTISTICK

Lot Number 7027897

Device Problem Fluid/Blood Leak (1250)

Patient Problem Underdose (2542)

Event Date 02/25/2019

Event Type  Injury  

Event Description

Administered mmr vaccine with bd integra 3 ml syringe and bd integra retracting needle combo.When administering mmr on the right thigh, the vaccine liquid leaked from the hub of the needle.The needle was properly screwed on and fully inserted into the subcutaneous tissue of the thigh.Unable to verify how much vaccine was administered into the patient.Per rn the patient will need to repeat the mmr vaccine in order to ensure the child received the proper dose of mmr.

• Brand Name: BD INTEGRA 3ML SYRINGE AND RETRACTING NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD
• MDR Report Key: 8377941
• MDR Text Key: 137524986
• Report Number: MW5084478
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Lot Number: 7027897
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 12 MO
• Patient Weight: 8