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

Device Problems Contamination (1120); Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Type  Other  

Event Description

The customer called the pharmacy to report that upon injecting this dose the syringe leaked out of the back side of the plunger.The leak resulted in contamination and it is estimated that the patient was injected with only about 15-20 mci of drug.The account was going to attempt to still scan the patient, but due to the issue experience they requested a credit for the dose.They also requested that the faulty syringe be reported to the manufacturer (duopross).

• Brand Name: DUOPROSS 3 ML SYRINGE 22G 1" NEEDLE
• Type of Device: 3 ML SYRINGE WITH NEEDLE
• Manufacturer (Section D): SHANGHAI MISAWA MEDICAL INDUSTRY CO. LTD.; shanghai ; CH
• MDR Report Key: 6099327
• MDR Text Key: 59921265
• Report Number: MW5065994
• Device Sequence Number: 1
• Product Code: FMI
• 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: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1