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

Lot Number 20150804

Device Problems Device Slipped (1584); Connection Problem (2900)

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

Event Type  Other  

Event Description

Needles do not maintain the luer-lok connection and do not stay attached to the syringes.

• Brand Name: DPS (DUOPROSS) SYRINGE WITH NEEDLE
• Type of Device: 3 ML SYRINGE WITH 22G 1" NEEDLE
• Manufacturer (Section D): SHANGHAI MISAWA MEDICAL INDUSTRY CO.; shanghai ; CH
• MDR Report Key: 5641228
• MDR Text Key: 44795784
• Report Number: MW5062156
• 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: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 20150804
• Type of Device Usage: N
• Patient Sequence Number: 1