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

Lot Number 20150809

Device Problem Connection Problem (2900)

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

Event Type  Other  

Event Description

Thirty-three of the 100 syringes in the multi-pack did not have needles attached.The syringes and the unattached needles had to be discarded.

• 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: 5535158
• MDR Text Key: 41534194
• Report Number: MW5061327
• 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: 03/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 20150809
• Type of Device Usage: N
• Patient Sequence Number: 1