MAUDE Adverse Event Report: SHANGHAI MISAWA MEDICAL INDUSTRY CO. LTD. DUOPROSS 3 ML SYRINGE; 3 ML SYRINGE

Lot Number 20160802

Device Problem Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Type  No Answer Provided  

Event Description

The needle hub is off center causing the needle to be at an angle that is not in the correct plane.See scanned pages.

• Brand Name: DUOPROSS 3 ML SYRINGE
• Type of Device: 3 ML SYRINGE
• Manufacturer (Section D): SHANGHAI MISAWA MEDICAL INDUSTRY CO. LTD. ; shanghai ; CH
• MDR Report Key: 6386911
• MDR Text Key: 69483923
• Report Number: MW5068338
• Device Sequence Number: 1
• Product Code: FMF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 20160802
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1