MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. 0.5ML FLUZONE INFLUENZA PREFILLED SYRINGE; SYRINGE, PISTON

Lot Number UT7096NA

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2020

Event Type  malfunction  

Event Description

Patient given second vaccine due to malfunction of vaccine syringe.Leaked at the needle hub and syringe.

• Brand Name: 0.5ML FLUZONE INFLUENZA PREFILLED SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 9954 mayland dr; richmond VA 23233
• MDR Report Key: 10830302
• MDR Text Key: 215967025
• Report Number: 10830302
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UT7096NA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2020
• Event Location: Other
• Date Report to Manufacturer: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1