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

Model Number	25G X 1"
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the safety needle provided in an ancillary convenience kit does not close properly or close completely, and is therefore a hazard for the employees.A user recently experienced a needle stick injury in the clinic.Users have indicated that the top click is not holding the needle down, and that it requires 2 clicks to hold the needle down.
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that can contain the safety needle component identified in part d of this report.The item ref#: and lot#: reported and identified have been confirmed as having been used in the assembly of convenience kits supplied by mckesson medical-surgical, inc.We have notified (b)(6) for awareness.

• Brand Name: DROP SAFE
• Common Device Name: HYPODERMIC SAFETY NEEDLE 25G X 1"
• Manufacturer (Section D): HTL-STREFA S.A.; ul. adamowek 7, 95-035; ozorkow, 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: 14777914
• Report Number: 3017368639-2022-00025
• Device Sequence Number: 4833021
• Product Code: FMI
• UDI-Device Identifier: 85907996099319
• UDI-Public: 85907996099319
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

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: 04/01/2026
• Device Model Number: 25G X 1"
• Device Catalogue Number: 6059
• Device Lot Number: SN25250018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/22/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown