MAUDE Adverse Event Report: DUOPROSS MEDITECH CORPORATION DPS; 25G X 1" HYPODERMIC SAFETY NEEDLE WITHOUT SYRINGE

Model Number	25G×1'' (0.5×25)
Medical Device Problem Codes	Retraction Problem (1536); Unintended Movement (3026)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that could contain the device from the manufacturer identified in section d.The item ref # and lot # reported and identified in section d have been confirmed as having been used in the assembly of convenience kits supplied by mckesson medical-surgical, inc.We have notified usarmy (b)(6) for awareness.
Event or Problem Description
Complainant reported multiple needlestick events where the safety shields on the orange 25gx1" needle completely falls off.

• Brand Name: DPS
• Common Device Name: 25G X 1" HYPODERMIC SAFETY NEEDLE WITHOUT SYRINGE
• Manufacturer (Section D): DUOPROSS MEDITECH CORPORATION; 27 sarah drive; farmingdale NY 11735
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland drive; richmond VA 23233
• Manufacturer Contact: akash gami ; 9954 mayland drive; richmond, VA 23233 ; 7792406767
• MDR Report Key: 17455205
• Report Number: 3017368639-2023-00009
• Device Sequence Number: 12584875
• Product Code: FMI
• UDI-Device Identifier: 06971352289020
• UDI-Public: 06971352289020
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2026
• Device Model Number: 25G×1'' (0.5×25)
• Device Catalogue Number: 100800000066
• Device Lot Number: W2105094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown