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

Lot Number 20160105

Device Problem Detachment Of Device Component (1104)

Patient Problems Exposure to Body Fluids (1745); Complaint, Ill-Defined (2331)

Event Type  Other  

Event Description

During administration, the needle on this duopross syringe fell off.The radiopharmaceutical contaminated the face of the nuclear medicine technologist.The technologist also stated that he previously had a needle come off a month or two before, but had no problems with administration.

• Brand Name: DPS (DUO PROSS) 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: 5811780
• MDR Text Key: 50189402
• Report Number: MW5063567
• 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: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 20160105
• Type of Device Usage: N
• Patient Sequence Number: 1