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

Model Number	100800000066
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Other
Event or Problem 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
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): DUOPROSS MEDITECH CORPORATION
• MDR Report Key: 16919582
• Report Number: MW5117487
• Device Sequence Number: 15163834
• Product Code: FMI
• UDI-Device Identifier: 06971352289020
• UDI-Public: (01)06971352289020
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 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 Expiration Date: 06/06/2026
• Device Model Number: 100800000066
• Device Lot Number: W2106077
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown