MAUDE Adverse Event Report: HTL-STREFA S.A. DROPSAFE SAFETY NEEDLE; 25G X 1" HYPODERMIC SAFETY NEEDLE

Model Number	25G
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that can 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 (b)(6) and (b)(6) for awareness.
Event or Problem Description
Complainant reported that the safety mechanism from the needle supplied with the ancillary kit failed and caused a blood borne pathogen exposure.The safety mechanism was closed, but the needle was sticking out of the safety mechanism, and when the caregiver went to dispose of it in the sharp container, it stuck them.

• Brand Name: DROPSAFE SAFETY NEEDLE
• Common Device Name: 25G X 1" HYPODERMIC SAFETY NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamówek 7; ozorków, lodz 95-03 5; PL 95-035
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland drive; richmond, VA 23233
• Manufacturer Contact: jo ann silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 17312849
• Report Number: 3017368639-2023-00006
• Device Sequence Number: 7157945
• Product Code: FMI
• UDI-Device Identifier: 85907996099319
• UDI-Public: 85907996099319
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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: 08/01/2026
• Device Model Number: 25G
• Device Catalogue Number: 6059
• Device Lot Number: SN25250059
• 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: 06/14/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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