MAUDE Adverse Event Report: SHANGHAI MISAWA MEDICAL INDUSTRY CO. LTD. DUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE; 3 ML SYRINGE WITH NEEDLE

Device Problems Detachment Of Device Component (1104); Contamination (1120)

Patient Problem Injury (2348)

Event Type  No Answer Provided  

Event Description

Hospital reported that while injecting a radiopharmaceutical, the needle became detached from the syringe.This caused the healthcare worker to contaminate himself with the radioactive material, contaminate the patient and contaminate the injection area.The healthcare worker reported the same thing happened earlier in the week but he did not report that incident.

• Brand Name: DUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE
• Type of Device: 3 ML SYRINGE WITH NEEDLE
• Manufacturer (Section D): SHANGHAI MISAWA MEDICAL INDUSTRY CO. LTD.; shanghai ; CH
• MDR Report Key: 6518657
• MDR Text Key: 73604050
• Report Number: MW5069275
• 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: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1