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

Lot Number 20180901

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

Almost 1/3 of the tray contained syringes with the needles detached.

• 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 / DUOPROSS MEDITECH CORP.
• MDR Report Key: 8515035
• MDR Text Key: 142081070
• Report Number: MW5085851
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 20180901
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1