MAUDE Adverse Event Report: SHANGHAI MISAWA MEDICAL INDUSTRY CO. LTD. DUOPROSS 3 ML SYRINGE 22G 1" NEEDLE; 3 ML SYRINGE WITH NEEDLE

Lot Number 20160406

Device Problems Contamination (1120); Radiation Leak (1357); Defective Device (2588)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  Other  

Event Description

Defective plunger allowed radioactive material to leak from syringe, contaminating the user and the work area.This resulted in a loss of material costing more than (b)(6) dollars.The patient had to be rescheduled, delaying patient care.

• Brand Name: DUOPROSS 3 ML SYRINGE 22G 1" NEEDLE
• Type of Device: 3 ML SYRINGE WITH NEEDLE
• Manufacturer (Section D): SHANGHAI MISAWA MEDICAL INDUSTRY CO. LTD. ; shanghai ; CH
• MDR Report Key: 6078636
• MDR Text Key: 59151755
• Report Number: MW5065813
• Device Sequence Number: 1
• Product Code: FMF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 20160406
• Type of Device Usage: N
• Patient Sequence Number: 1