MAUDE Adverse Event Report: DUOPROSS MEDITECH CORPORATION SAFETY NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 100800000066

Device Problems Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

The needle is very flimsy.It bends when trying to penetrate a medication vial, i have also seen it bend when trying to give an injection (on a human).And now today, the needle was so flimsy it bent when trying to activate the safety cap over the needle.So only a small portion of the needle is in the safety cap and a larger portion of the sharp needle is protruding outside of the edges of the safety cap.(b)(6).Submission id: (b)(4).

• Brand Name: SAFETY NEEDLE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): DUOPROSS MEDITECH CORPORATION
• MDR Report Key: 16919582
• MDR Text Key: 315276245
• Report Number: MW5117487
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 100800000066
• Device Lot Number: W2106077
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2023
• Patient Sequence Number: 1