MAUDE Adverse Event Report: DUOPROSS MEDITECH CORPORATION DUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE; SYRINGE PISTON

Lot Number 20180704

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Type  No Answer Provided  

Event Description

Syringe barrels have cracks that allow liquid to be released as the plunger is extended or depressed.Shanghai misawa medical industry co., ltd., (b)(4).

• Brand Name: DUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE
• Type of Device: SYRINGE PISTON
• Manufacturer (Section D): DUOPROSS MEDITECH CORPORATION
• MDR Report Key: 8208525
• MDR Text Key: 131967806
• Report Number: MW5082730
• 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: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 20180704
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1